Podcasts about Merck

Welcome to PsychEd, the psychiatry podcast for medical learners, by medical learners. This short episode covers Types of SubstancesHosts: Sara Abrahamson, Shaoyuan Wang and Kate Braithwaite.Audio Editing: Kate BraithwaiteReferences:American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-5, text revision (DSM-5-TR). 5th ed. Washington, D.C.: American Psychiatric Association Publishing; 2022.CAMH. (2013). Inhalants. Inhalants | CAMHCAMH. (2010). Cocaine and Crack. https://www.camh.ca/en/health-info/mental-illness-and-addiction-index/cocaineCAMH. (2012). Amphetamines. https://www.camh.ca/en/health-info/mental-illness-and-addiction-index/amphetamines#:~:text=Chronic%20use%20of%20amphetamines%20can,can%20also%20cause%20amphetamine%20psychosis.Chae J, Marsden J and Sutherland A. (2024, August 21). Benzodiazepine Withdrawal. Emergency Care BC. Benzodiazepine Withdrawal : Emergency Care BCChildHealthBC. (2023, September 21). Common Street names for Substances. https://childhealthbc.ca/mhsu/common_streetnames_substances/printfileJauch EC. (2023, January 18) Inhalants Clinical Presentation. Medscape. Inhalants Clinical Presentation: History, Physical, CausesKaye, AD, Staser, AN, Mccollins, TS, Zheng, J, Berry, FA, Burroughs, CR, Heisler, M, Mouhaffel, A, Ahmadzadeh, S, Kaye, AM, Shekoohi, S, & Varrassi, G. (2024). Delirium Tremens: A Review of Clinical Studies. Cureus, 16(4), e57601. https://doi.org/10.7759/cureus.57601Long N. (2020, November 3). GHB toxicity. Life in the Fast Lane. GHB toxicity • LITFL • Toxicology Library ToxicantMedx. (2025, November 26). Understanding What is the MOA of Alcohol: A Pharmacological Perspective. What is the MOA of Alcohol? Explained: Receptors and EffectsMendelson, J. H., & Mello, N. K. (1996). Management of cocaine abuse and dependence. The New England journal of medicine, 334(15), 965–972. https://doi.org/10.1056/NEJM199604113341507Nichols DE. Hallucinogens. Pharmacol Ther. 2004 Feb;101(2):131-81. doi: 10.1016/j.pharmthera.2003.11.002.Nickson C. (2024, December 18). Sedative toxidrome. Life in the Fast Lane. Sedative Toxidrome • LITFL • CCC ToxicologyPorter RS, Kaplan JL, Homeier BP, editors. The Merck manual of diagnosis and therapy. 20th ed. Kenilworth (NJ): Merck Sharp & Dohme; 2018.PsychDB. (2021, March). Opioid Intoxication. Opioid Intoxication - PsychDBPsychDB. (2023, October). Opioid Withdrawal. Opioid Withdrawal - PsychDBPsychDB. (2023 February). Cannabis Withdrawal. Cannabis Withdrawal - PsychDBRoth BL, Gumpper RH. Psychedelics as Transformative Therapeutics. Am J Psychiatry. 2023 May 1;180(5):317-20.Vollenweider FX, Kometer M. The neurobiology of psychedelic drugs: implications for the treatment of mood disorders. Nat Rev Neurosci. 2010 Sep;11(9):642-51. doi: 10.1038/nrn2884.

A look at Inflammatory Bowel Disease (IBD), more specifically the two main forms of IBD which are Ulcerative Colitis and Crohn's Disease, going through each condition as well as looking at the differences between Ulcerative Colitis and Crohn's disease. Includes the signs and symptoms of each, including extraintestinal manifestations of inflammatory bowel disease, as well as differences in the histology. PDFs available at: https://rhesusmedicine.com/pages/gastroenterologyConsider subscribing (if you found any of the info useful!): https://www.youtube.com/channel/UCRks8wB6vgz0E7buP0L_5RQ?sub_confirmation=1Buy Us A Coffee!: https://www.buymeacoffee.com/rhesusmedicineTimestamps:0:00 What is Inflammatory Bowel Disease?0:15 Ulcerative Colitis and Crohn's Disease Epidemiology1:08 Signs and Symptoms of Inflammatory Bowel Disease / Signs and Symptoms of Ulcerative Colitis and Crohn's Disease3:19 Extraintestinal Manifestations of Inflammatory Bowel Disease4:48 Inflammatory Bowel Disease Pathology5:07 Risk Factors for Ulcerative Colitis and Crohn's Disease / Risk Factors of Inflammatory Bowel Disease5:47 Diagnosis of Ulcerative Colitis and Crohn's Disease / Inflammatory Bowel Disease Diagnosis6:51 Inflammatory Bowel Disease Histology / Ulcerative Colitis v Crohn's Disease Histology7:52 Treatment of Inflammatory Bowel Disease / Ulcerative Colitis and Crohn's Disease TreatmentLINK TO SOCIAL MEDIA: https://www.instagram.com/rhesusmedicine/ReferencesCrohn's & Colitis Foundation (2019) Updated IBD Factbook. Crohn's & Colitis Foundation. Available at: https://www.Crohn'scolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdfWalfish, A.E. and Ching Companioni, R.A. (2023) ‘Overview of inflammatory bowel disease', MSD Manual Professional Edition. Merck & Co., Inc. Available at: https://www.msdmanuals.com/professional/gastrointestinal-disorders/inflammatory-bowel-disease-ibd/overview-of-inflammatory-bowel-diseaseWaugh, N., Cummins, E., Royle, P. et al. (2013) Comparison of Ulcerative Colitis, Crohn's disease, irritable bowel syndrome and coeliac disease, in Faecal calprotectin testing for differentiating amongst inflammatory and non-inflammatory bowel diseases: systematic review and economic evaluation. Southampton: NIHR Journals Library. Available at: https://www.ncbi.nlm.nih.gov/books/NBK261307/Disclaimer: Please remember this video and all content from Rhesus Medicine is for educational and entertainment purposes only and is not a guide to diagnose or to treat any form of condition. The content is not to be used to guide clinical practice and is not medical advice. Please consult a healthcare professional for medical advice.

In this BG2 guest interview, Altimeter partner Apoorv Agrawal sits down with Ali Ghodsi (Databricks) and Arvind Jain (Glean) for a candid, operator-level discussion on what's actually working in enterprise AI—and what isn't.They unpack why 95% of AI projects fail, why LLMs are rapidly commoditizing, and why durable advantage is shifting to proprietary data, agentic systems, and workflow integration. The conversation dives deep into real-world use cases across finance, healthcare, and retail; the debate over whether we already have AGI; and how AI spend, CapEx, and valuation bubbles will realistically play out. A must-watch for builder, and investors navigating the AI transition inside real organizations.Timestamps:(00:00) Intro(01:00) Consumer AI vs. Enterprise Reality(02:15) Why 95% of AI Projects Fail(04:15) RBC, Merck, and 7-Eleven Use Cases(06:45) What Actually Makes AI Work(07:00) LLMs Are Commodities—Data Is the Moat(08:45) Failed AI Bets at Databricks & Glean(11:00) RPA vs. Generative AI(14:15) Advice for CIOs Planning AI Budgets(16:00) AI CapEx and the Revenue Math(18:00) The Three Camps of AI(21:00) Making AI Useful Inside Enterprises(24:30) Why Apps Capture the Value(30:00) The Future of UI, Voice, and Data Entry(37:30) Rapid Fire: Winners, Bubbles, Long/ShortProduced by Dan ShevchukMusic by Yung SpielbergAvailable on Apple, Spotify, www.bg2pod.comFollow:Apoorv Agrawal @apoorv03 https://x.com/apoorv03BG2 Pod @bg2pod https://x.com/BG2Pod

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Jennifer Sheller, SVP and Head of Global Clinical Trial Operations at Merck talks about simplifying trial protocols and what she likes about Merck's hybrid functional service provider model for conducting trials in over 60 countries. Jennifer shares her experiences integrating Merck's acquisitions without breaking studies or losing people, using new technology to improve trial operations, and co-designing studies with trial sites for agility and speed.  Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

What if our smartest health tools still miss the people who need them most? We sit down with AI and digital health scientist Mireille Gomes to examine how innovation can serve dignity, not just efficiency—and what it takes to build technology that works from Geneva to rural clinics without electricity.The journey of Mireille Gomes spans continents and roles, from vaccine strategy at Gavi to AI diagnostics at Merck. Together, we unpack the real barriers to deployment—uneven infrastructure, overworked staff, and data voids that erase entire communities from the record. We look at consent‑first design, why open data must be truly anonymous, and how representation in civil registration and vital statistics underpins every “fair” algorithm. You'll hear pragmatic ideas for triage tools that flag urgency in seconds, health education in local languages, and micro‑local models that adapt to context while sharing standards globally.We also push on the hard questions: Who decides which data matters? Can algorithms be biased toward justice if the world is not? Where is the line between breakthrough and overreach when crises demand speed? Mirielle argues for building abuse cases into development, testing for misuse before launch, and preserving community storytelling—especially Indigenous knowledge—alongside dashboards. The goal is health equity by design, so no one's care depends on their birthplace or bandwidth.If you care about AI in healthcare, data justice, and solutions that actually work on the ground, this conversation offers a clear roadmap and candid guardrails. If it resonates, subscribe, leave a review, and share it with someone shaping the future of digital health.Send us a textCheck out "Protection for the Inventive Mind" – available now on Amazon in print and Kindle formats. The views and opinions expressed (by the host and guest(s)) in this podcast are strictly their own and do not necessarily reflect the official policy or position of the entities with which they may be affiliated. This podcast should in no way be construed as promoting or criticizing any particular government policy, institutional position, private interest or commercial entity. Any content provided is for informational and educational purposes only.

"I always say, you can't learn how to swim if you don't jump into the water. And it's so important for people to be able to jump into the water and to really test it out."

US equity markets advanced for a third consecutive session to open the holiday-shortened week - Dow rose +228-points or +0.47%, with Merck & Co (up +3.59%) the leading performer in the 30-stock index. Honeywell International fell -1.58% after the aerospace and industrial-automation company lowered its full-year earnings outlook and updated investors on its expectations surrounding the Flexjet lawsuit. Nike Inc -2.54%.The broader S&P500 gained +0.64%, with Materials (up +1.35%), Financials (+1.25%), Industrials (+1.11%) and Energy (+1.08%) all rising over >1% to lead ten of the eleven primary sectors higher. Consumer Staples (down -0.41%) was the only primary sector to settle in the red.

US equity markets advanced for a third consecutive session to open the holiday-shortened week - Dow rose +228-points or +0.47%, with Merck & Co (up +3.59%) the leading performer in the 30-stock index. Honeywell International fell -1.58% after the aerospace and industrial-automation company lowered its full-year earnings outlook and updated investors on its expectations surrounding the Flexjet lawsuit. Nike Inc -2.54%.

Shop Talk explores nostalgic themes surrounding defunct retail brands. But first, innovative toilet technology from Japan and the first photo booth museum in NYC Caught Our Eye. Kenneth Frazier, former CEO of Merck and the first African American to lead a major American Pharma Co., is the Business Birthday. We're all business. Except when we're not. Apple Podcasts: apple.co/1WwDBrC Spotify: spoti.fi/2pC19B1 iHeart Radio: bit.ly/4aza5LW Tunein: bit.ly/1SE3NMb YouTube Music: bit.ly/43T8Y81 Pandora: pdora.co/2pEfctj YouTube: bit.ly/1spAF5a Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Two-time Emmy and Three-time NAACP Image Award-winning, television Executive Producer Rushion McDonald interviewed Ken Taunton. Founder and president of The Royster Group, a nationally recognized, certified Black-owned professional staffing firm. Here's a breakdown of the key themes and takeaways:

Two-time Emmy and Three-time NAACP Image Award-winning, television Executive Producer Rushion McDonald interviewed Ken Taunton. Founder and president of The Royster Group, a nationally recognized, certified Black-owned professional staffing firm. Here's a breakdown of the key themes and takeaways:

Two-time Emmy and Three-time NAACP Image Award-winning, television Executive Producer Rushion McDonald interviewed Ken Taunton. Founder and president of The Royster Group, a nationally recognized, certified Black-owned professional staffing firm. Here's a breakdown of the key themes and takeaways:

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. As we close out the year 2025, it's clear that the pharmaceutical and biotech industries have experienced a period of significant transformation. This year has been marked by groundbreaking drug approvals, strategic partnerships, and a focus on innovative therapies that promise to redefine patient care.One of the standout achievements this year comes from GlaxoSmithKline, which received approval from the U.S. FDA for its ultra-long-acting biologic, Exdensur, aimed at treating severe asthma with an eosinophilic phenotype in adolescents and adults. This approval underscores the growing trend toward personalized medicine and biologics, offering new hope for patients with chronic respiratory conditions by providing more sustainable and personalized treatment options.In the oncology sector, Merck's Keytruda and Astellas Pharma's Padcev have demonstrated significant overall survival benefits when used as perioperative treatments for cisplatin-eligible muscle-invasive bladder cancer. This combination therapy of a PD-1 checkpoint inhibitor and an antibody-drug conjugate highlights the evolving landscape of cancer treatment, emphasizing the role of immunotherapy and targeted therapies in improving patient outcomes in challenging cancer subtypes.However, not all developments have been positive. Hansa Biopharma faced challenges with its kidney transplant drug, imlifidase. Despite success in kidney transplant trials, it failed to achieve desired results in treating anti-glomerular basement membrane disease. This serves as a reminder of the complexities involved in drug repurposing efforts within autoimmune diseases.Alnylam Pharmaceuticals announced a significant investment to enhance its Norton, Massachusetts facility into a dedicated site for small interfering RNA (siRNA) production. This move reflects the industry's shift towards RNA-based therapies that offer targeted gene-silencing capabilities and positions Alnylam at the forefront of RNAi therapeutics production.In another promising development, ImmunityBio reported positive data from its QUILT-3.032 study on Anktiva for BCG-unresponsive non-muscle-invasive bladder cancer with high-grade papillary disease. The potential expansion of Anktiva's use reinforces the importance of personalized immunotherapies in oncology.The launch of Ambros Therapeutics with $125 million in Series A funding highlights efforts to develop non-opioid pain medications already approved abroad. This initiative addresses chronic pain management without relying on opioids, potentially advancing analgesic therapies amidst the ongoing opioid crisis.In China, Fosun Pharma's acquisition of a majority stake in Green Valley Pharmaceuticals aims to revive a controversial seaweed-derived Alzheimer's medication. Despite skepticism over its efficacy, this investment signals continued innovation efforts amid growing demand for effective Alzheimer's treatments.Siemens Healthineers' partnership with Alzpath to incorporate pTau-217 antibodies into its Atellica immunoassay platforms marks a significant step forward in Alzheimer's diagnostics. This collaboration aims to enhance biomarker detection capabilities crucial for early diagnosis and intervention strategies in neurodegenerative diseases.On the strategic front, Bristol Myers Squibb entered into a substantial research agreement with Harbour BioMed valued at up to $1.1 billion. This deal underscores Big Pharma's ongoing pursuit of alliances to advance therapeutic pipelines and antibody technologies.Finally, Cencora's acquisition of OneOncology for $5 billion underscores consolidation trends within specialty practice networks. By valuing OneOncology at $7.4 billion, this acquisition reflects the growing importance of integrated oncology care models and collaborative netSupport the show

In Episode 33, Dr. Aly-Khan Lalani and Dr. Christoper Wallis sit down with Dr. Daniel Heng, Clinical Professor at the University of Calgary and Head of Medical Oncology at the Arthur J.E. Child Comprehensive Cancer Centre. Together, they explore the full landscape of mentorship and sponsorship in academic medicine, from what makes an exceptional mentee to how leaders identify and support rising talent.The View on GU with Lalani & Wallis integrates key clinical data from major conferences and high impact publications, sharing meaningful take home messages for practising clinicians in the field of genitourinary (GU) cancers. Learn more about The View on GU: theviewongu.caThis podcast has been made possible through unrestricted financial support by Novartis, Bayer, Astellas, Tolmar, Ipsen, J&J, Merck, Pfizer, Eisai and AbbVie.

This episode is part of the special series Empowered Intimacy: Getting Your Sexy Back After Breast Cancer, where getting your sexy back is about reclaiming confidence, connection, and desire after a breast cancer diagnosis. Melissa Berry sits down with Chelsey Pickthorn, a patient advocate living with stage four triple-negative breast cancer, and Dr. Don Dizon, Chief of Hematology and Oncology at Tufts Medicine and a national leader in sexual health and inclusive cancer care.  They explore the challenges LGBTQ+ individuals face with intimacy, dating, body image, and relationships after a cancer diagnosis. Chelsey shares her experiences navigating disclosure, reconstruction, caregiving, and connection, while Dr. Dizon highlights gaps in healthcare for LGBTQ+ patients.  This honest and hopeful conversation offers guidance, empowerment, and advocacy for inclusive care. Thank you to Lilly, Merck, and Novartis for making this episode possible.  

The Big Unlock · Gregory Goldmacher, M.D., Associate Vice President in Clinical Research, and Head of Clinical Imaging & Pathology, Merck Research Laboratories In this episode, Dr. Greg Goldmacher, Associate VP of Clinical Research at Merck, known as MSD outside of the United States and Canada, explains how AI is transforming imaging, clinical trials, and early-stage drug development. Greg describes endpoints as the core of every clinical trial, since they determine whether a therapy is safe or effective. He notes that AI is not new to imaging and aligns well with pattern recognition, yet its real value lies in identifying details that humans often miss. Greg stresses that drug development still depends on huge volumes of data spread across legacy systems. Without strong data standardization, AI cannot deliver reliable results. He also points to the FDA's evolving guidance on AI and emphasizes the need for rigorous validation before using AI-derived measurements for regulatory decisions. Greg highlights the opportunity to improve efficiency, reduce human burden, and generate more consistent insights. With thoughtful adoption, AI can support better decisions in clinical development and improve outcomes for patients. Take a listen.

JCO PO author Dr. Shilpa Gupta at Cleveland Clinic Children's Hospital shares insights into her article, "Fibroblast Growth Factor Receptor 3 (FGFR3) Alteration Status and Outcomes on Immune Checkpoint Inhibitors (ICPI) in Patients with Metastatic Urothelial Carcinoma". Host Dr. Rafeh Naqash and Dr. Gupta discuss how FGFR3 combined with TMB emerged as a biomarker that may be predictive for response to ICPI in mUC. TRANSCRIPT Dr. Rafeh Naqash: Hello and welcome to JCO Precision Oncology Conversations, where we bring you engaging conversations with authors of clinically relevant and highly significant JCO PO articles. I'm your host, Dr. Rafeh Naqash, podcast editor for JCO Precision Oncology and Associate Professor at the OU Health Stephenson Cancer Center. Today I am excited to be joined by Dr. Shilpa Gupta, Director of Genitourinary Medical Oncology at the Cancer Institute and co-leader of the GU Oncology Program at the Cleveland Clinic, and also lead author of the JCO PO article titled "Fibroblast Growth Factor Receptor 3 Alteration Status and Outcomes on Immune Checkpoint Inhibitors in Patients With Metastatic Urothelial Carcinoma." At the time of this recording, our guest's disclosures will be linked in the transcript. Shilpa, welcome again to the podcast. Thank you for joining us today. Dr. Shilpa Gupta: Thank you, Rafeh. Honor to be here with you again. Dr. Rafeh Naqash: It is nice to connect with you again after two years, approximately. I think we were in our infancy of our JCO PO podcast when we had you first time, and it has been an interesting journey since then. Dr. Shilpa Gupta: Absolutely. Dr. Rafeh Naqash: Well, excited to talk to you about this article that you published. Wanted to first understand what is the genomic landscape of urothelial cancer in general, and why should we be interested in FGFR3 alterations specifically? Dr. Shilpa Gupta: Bladder cancer or urothelial cancer is a very heterogeneous cancer. And while we find there is a lot of mutations can be there, you know, like BRCA1, 2, in HER2, in FGFR, we never really understood what is driving the cancer. Like a lot of old studies with targeted therapies did not really work. For example, we think VEGF can be upregulated, but VEGF inhibitors have not really shown definite promise so far. Now, FGFR3 receptor is the only therapeutic target so far that has an FDA approved therapy for treating metastatic urothelial cancer patients, and erdafitinib was approved in 2019 for patients whose tumors overexpressed FGFR3 mutations, alterations, or fusions. And in the landscape of bladder cancer, it is important because in patients with non-muscle invasive bladder cancer, about 70 to 80% patients can have this FGFR3. But as patients become metastatic, the alterations are seen in, you know, only about 10% of patients. So the clinical trials that got the erdafitinib approved actually used archival tumor from local cancer. So when in the real world, we don't see a lot of patients if we are trying to do metastatic lesion biopsies. And why it is important to know this is because that is the only targeted therapy available for our patients right now. Dr. Rafeh Naqash: Thank you for giving us that overview. Now, on the clinical side, there is obviously some interesting data for FGFR3 on the mutation side and the fusion side. In your clinical practice, do you tend to approach these patients differently when you have a mutation versus when you have a fusion? Dr. Shilpa Gupta: We can use the treatment regardless of that. Dr. Rafeh Naqash: I recently remember I had a patient with lung cancer, squamous lung cancer, who also had a synchronous bladder mass. And the first thought from multiple colleagues was that this is metastatic lung. And interestingly, the liquid biopsy ended up showing an FGFR3-TACC fusion, which we generally don't see in squamous lung cancers. And then eventually, I was able to convince our GU colleagues, urologists, to get a biopsy. They did a transurethral resection of this tumor, ended up being primary urothelial and synchronous lung, which again, going back to the FGFR3 story, I saw in your paper there is a mention of FGFR3-TACC fusions. Anything interesting that you find with these fusions as far as biology or tumor behavior is concerned? Dr. Shilpa Gupta: We found in our paper of all the patients that were sequenced that 20% had the pathognomonic FGFR3 alteration, and the most common were the S249C, and the FGFR3-TACC3 fusion was in 45 patients. And basically I will say that we didn't want to generate too much as to fusion or the differences in that. The key aspect of this paper was that historically there were these anecdotal reports saying that patients who have FGFR alterations or mutations, they may not respond well to checkpoint inhibitors because they have the luminal subtype. And these were backed by some preclinical data and small anecdotal reports. But since then, we have seen that, and that's why a lot of people would say that if somebody's tumor has FGFR3, don't give them immunotherapy, give them erdafitinib first, right? So then we had this Phase 3 trial called the THOR trial, which actually showed that giving erdafitinib before pembrolizumab was not better. That debunked that myth, and we are actually reiterating that because in our work we found that patients who had FGFR3 alterations or fusions, and if they also have TMB-high, they actually respond very well to single agent immunotherapy. And that is, I think, very important because it tells us that we are not really seeing that so-called potential of resistance to immunotherapy in these patients. So to answer your question, yeah, we did see those differences, but I wouldn't say that any one marker is more prominent. Dr. Rafeh Naqash: The analogy is kind of similar to what we see in lung cancer with these mutations called STK11/KEAP1, which are also present in some other tumors. And one of the questions that I don't think has been answered is when you have in lung cancer, if you extrapolate this, where doublet or single agent immunotherapy doesn't do as well in tumors that are STK11 mutated. But then if you have a high TMB, question is does that TMB supersede or trump the actual mutation? Could that be one reason why you see the TMB-high but FGFR3 altered tumors in your dataset responding or having better outcomes to immunotherapy where potentially there is just more neoantigens and that results in a more durable or perhaps better response to checkpoint therapy? Dr. Shilpa Gupta: It could be. But you know, the patients who have FGFR alterations are not that many, right? So we have already seen that just patients with TMB-high respond very well to immunotherapy. Our last podcast was actually on that, regardless of PD-L1 that was a better predictor of response to immunotherapy. So I think it's not clear if this is adding more chances of response or not, because either way they would respond. But what we didn't see, which was good, that if they had FGFR3, it's not really downplaying the fact that they have TMB-high and that patients are not responding to immunotherapy. So we saw that regardless, and that was very reassuring. Dr. Rafeh Naqash: So if tomorrow in your clinic you had an individual with an FGFR3 alteration but TMB-high, I guess one could be comfortable just going ahead with immunotherapy, which is what the THOR trial as you mentioned. Dr. Shilpa Gupta: Yes, absolutely. And you know, when you look at the toxicity profiles of pembrolizumab and erdafitinib, really patients really struggle with using the FGFR3 inhibitors. And of course, if they have to use it, we have to, and we reserve it for patients. But it's not an easy drug to tolerate. Currently the landscape is such that, you know, frontline therapy has now evolved with an ADC and immunotherapy combinations. So really if patients progress and have FGFR3 alterations, we are using erdafitinib. But let's say if there were a situation where a patient has had chemotherapy, no immunotherapy, and they have FGFR3 upregulation and TMB-high, yes, I would be comfortable with using only pembrolizumab. And that really ties well together what we saw in the THOR trial as well. Dr. Rafeh Naqash: Going to the clinical applications, you mentioned a little bit of this in the manuscript, is combination therapies. You alluded to it a second back. Everything tends to get combined with checkpoint therapy these days, as you've seen with the frontline urothelial, pembrolizumab with an ADC. What is the landscape like as far as some of these FGFR alterations are concerned? Is it reasonable to combine some of those drugs with immune checkpoint therapy? And what are some of the toxicity patterns that you've potentially seen in your experience? Dr. Shilpa Gupta: So there was indeed a trial called the NORSE trial. It was a randomized trial but not a comparative cohort, where they looked at FGFR altered patients. And when they combined erdafitinib plus cetrelimab, that did numerically the response rates were much higher than those who got just erdafitinib. So yeah, the combination is definitely doable. There is no overlapping toxicities. But unfortunately that combination has not really moved forward to a Phase 3 trial because it's so challenging to enroll patients with such kind of rare mutations on large trials, especially to do registration trials. And since then the frontline therapy has evolved to enfortumab vedotin and pembrolizumab. I know there is an early phase trial looking at a next generation FGFR inhibitor. There is a triplet combination looking in Phase 1 setting with a next generation FGFR inhibitor with EV-pembro. However, it's not a randomized trial. So you know, I worry about such kinds of combinations where we don't have a path for registration. And in the four patients that have been treated, four or five patients in the early phase as a part of basket trial, the toxicities were a lot, you know, when you combine the EV-pembro and an FGFR3 inhibitor, we see more and more toxicity. So the big question is do we really need the "kitchen sink" approach when we have a very good doublet, or unless the bar is so high with the doublet, like what are we trying to add at the expense of patient toxicity and quality of life is the big question in my mind. Dr. Rafeh Naqash: Going back to your manuscript specifically, there could be a composite biomarker. You point out like FGFR in addition to FGFR TMB ends up being predictive prognostic there. So that could potentially be used as an approach to stratify patients as far as treatment, whether it's a single agent versus combination. Maybe the TMB-low/FGFR3 mutated require a combination, but the TMB-high/FGFR mutated don't require a combination, right? Dr. Shilpa Gupta: No, that's a great point, yeah. Dr. Rafeh Naqash: But again, very interesting, intriguing concepts that you've alluded to and described in this manuscript. Now, a quick take on how things have changed in the bladder cancer space in the last two years. We did a podcast with you regarding some biomarkers as you mentioned two years back. So I really would like to spend the next minute to two to understand how have things changed in the bladder cancer space? What are some of the exciting things that were not there two years back that are in practice now? And how do you anticipate the next two years to be like? Maybe we'll have another podcast with you in another two years when the space will have changed even more. Dr. Shilpa Gupta: Certainly a lot has happened in the two years, you know. EV-pembro became the universal frontline standard, right? We have really moved away from cisplatin eligibility in metastatic setting because anybody would benefit from EV-pembro regardless of whether they are candidates for cisplatin or not, which historically was relevant. And just two days ago, we saw that EV-pembro has now been approved for localized bladder cancer for patients who are cisplatin ineligible or refusing. So, you know, this very effective regimen moving into earlier setting, we now have to really think of good treatment options in the metastatic setting, right? So I think that's where a lot of these novel combinations may come up. And what else we've seen is in a tumor agnostic trial called the DESTINY-PanTumor trial, patients who had HER2 3+ on immunohistochemistry, we saw the drug approval for T-DXd, and I think that has kind of reinvigorated the interest in HER2 in bladder cancer, because in the past targeting HER2 really didn't work. And we still don't know if HER2 is a driver or not. And at ESMO this year, we saw an excellent study coming out of China with DV which is targeting HER2, and toripalimab, which is a Chinese checkpoint inhibitor, showing pretty much similar results to what we saw with EV-pembro. Now, you know, not to do cross-trial comparisons, but that was really an amazing, amazing study. It was in the presidential session. And I think the big question is: does that really tell us that HER2-low patients will not benefit? Because that included 1+, 2+, 3+. So that part we really don't know, and I think we want to study from the EV-302 how the HER2 positive patients did with EV and pembro. So that's an additional option, at least in China, and hopefully if it gets approved here, there is a trial going on with DV and pembro. And lastly, we've seen a very promising biomarker, like ctDNA, for the first time in bladder cancer in the adjuvant setting guiding treatment with adjuvant atezolizumab. So patients who were ctDNA positive derived overall survival and recurrence-free survival benefit. So that could help us select moving forward with more studies. We can spare unnecessary checkpoint inhibitors in patients who are not going to benefit. So I think there is a lot happening in our field, and this will help do more studies because we already have the next generation FGFR inhibitors which don't have the toxicities that erdafitinib comes with. And combining those with these novel ADCs and checkpoint inhibitors, you know, using maybe TMB as a biomarker, because we really need to move away from PD-L1 in bladder cancer. It's shown no utility whatsoever, but TMB has. Dr. Rafeh Naqash: Well, thank you so much, Shilpa, for that tour de force of how things have changed in bladder cancer. There used to be a time when lung and melanoma used to lead this space in terms of the number of approvals, the biomarker development. It looks like bladder cancer is shifting the trend at this stage. So definitely exciting to see all the new changes that are coming up. I'd like to spend another minute and a half on your career. You've obviously been a leader and example for many people in the GU space and beyond. Could you, for the sake of our early career especially, the trainees and other listeners, describe how you focused on things that you're currently leading as a leader, and how you shaped your career trajectory over the last 10 years? Dr. Shilpa Gupta: That's a really important question, Rafeh, and you and I have had these discussions before, you know, being an IMG on visas like you, and being in different places. I think I try to make the most of it, you know, instead of focusing on the setbacks or the negative things. Like tried to grab the opportunities that came along. When I was at Moffitt, got to get involved with the Phase 1 trial of pembrolizumab in different tumor types. And just keeping my options open, you know, getting into the bladder cancer at that time when I wanted to really do only prostate, but it was a good idea for me to keep my options open and got all these opportunities that I made use of. I think an important thing is to, like you said, you know, have a focus. So I am trying to focus more on biomarkers that, you know, we know that 70% patients will respond to EV-pembro, right? But what about the remaining 30%? Like, so I'm really trying to understand what determines hyperprogressors with such effective regimens who we really struggle with in the clinic. They really don't do well with anything we give them after that. So we are doing some work with that and also trying to focus on PROs and kind of patient-reported outcomes. And a special interest that I've now developed and working on it is young-onset bladder cancer. You know, the colorectal cancer world has made a lot of progress and we are really far behind. And bladder cancer has historically been a disease of the elderly, which is not the case anymore. We are seeing patients in their 30s and 40s. So we launched this young-onset bladder cancer initiative at a Bladder Cancer Advocacy Network meeting and now looking at more deep dive and creating a working group around that. But yeah, you know, I would say that my philosophy has been to just take the best out of the situation I'm in, no matter where I am. And it has just helped shape my career where I am, despite everything. Dr. Rafeh Naqash: Well, thank you again. It is always a pleasure to learn from your experiences and things that you have helped lead. Appreciate all your insights, and thank you for publishing with JCO PO. Hopefully we will see more of your biomarker work being published and perhaps bring you for another podcast in a couple of years. Dr. Shilpa Gupta: Yeah, thank you, Rafeh, for the opportunity. And thanks to JCO PO for making these podcasts for our readers. So thanks a lot. Dr. Rafeh Naqash: Thank you for listening to JCO Precision Oncology Conversations. Don't forget to give us a rating or review and be sure to subscribe so you never miss an episode. You can find all ASCO shows at asco.org/podcast. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. DISCLOSURES Dr. Shilpa Gupta Stock and Other Ownership Interests: Company: BioNTech SE,  Nektar Consulting or Advisory Role: Company: Gilead Sciences, Pfizer, Merck, Foundation Medicine, Bristol-Myers Squibb/Medarex, Natera, Astellas Pharma, AstraZeneca, Novartis, Johnson & Johnson/Janssen Research Funding: Recipient: Your Institution Company: Bristol Myers Squibb Foundation, Merck, Roche/Genentech, EMD Serono, Exelixis, Novartis, Tyra Biosciences, Pfizer, Convergent Therapeutics, Acrivon Therapeutics, Flare Therapeutics, Amgen Travel, Accommodations, Expenses: Company: Pfizer, Astellas Pharma, Merck    

Send us an inquiry through a text message here!Welcome to a special episode of The Veterinary Roundtable! We're excited to welcome Dr. Nikhil Joshi, Senior Professional Services Veterinarian at Merck Animal Health! With extensive veterinary experience, he's here to dive into everything you need to know about Bravecto Quantum.Do you have a question, story, or inquiry for The Veterinary Roundtable? Send us a text from the link above, ask us on any social media platform, or email theveterinaryroundtable@gmail.com!Episodes of The Veterinary Roundtable are on all podcast services along with video form on YouTube!Timestamps00:00 Intro05:41 Bravecto Quantum Basics08:06 Species of Ticks Bravecto Quantum Covers08:43 Ideal Fit For This Product09:54 Talking To An Owner About Coverage11:43 What Makes the Lone Star Tick So Hard To Remove13:43 What Happens If There Are Gaps in the Shots14:33 How Does It Dissolve To Last a Year17:07 Dealing with Social Media Backlash19:38 Dogs That Aren't Ideal Candidates For It22:28 Precautions and Side Effects to Consider25:03 Cost Concerns26:38 What Should Clients Ask Their Vets27:29 The Tick Life Cycle30:18 Human Tickborne Disease32:05 Does the Injection Break the Life Cycle Better35:50 Injection Concerns37:48 Bravecto Promise39:46 Best Storing and Usage Practices40:39 What Drives Owners to Make the Switch43:05 Usage on Pets with Seizure Disorders44:07 Final Thoughts45:07 Outro

Marco e Merck provano a decifrare la strana partita contro i Colt di un redivivo Philip Rivers

AABP Executive Director Dr. Fred Gingrich is joined by Dr. Angel Abuelo, AABP member on faculty at Michigan State University College of Veterinary Medicine. Abuelo presented at the 2025 AABP Recent Graduate Conference in Norman, Okla. on managing Salmonella Dublin. AABP members can listen to this presentation for free by accessing the online CE portal on this page or download the BCI Mobile Conference app from your device's store.  Salmonella Dublin is a host-adapted pathogen that results in high morbidity and mortality due to the systemic nature of the disease in calves and in most cases, the pathogen exhibits multi-drug resistance. This pathogen also has implications for human health as a zoonotic disease. Abuelo discusses the clinical presentation in calves is primarily respiratory disease and the carrier state that can be seen in adult cows that serve as a continuous reservoir to maintain the disease on a farm. Diagnostics should include multiple tissues from deceased calves that are necropsied. The best sample to submit in live calves is not feces, but aseptically collected blood cultures.  Abuelo discusses the nuances of treatment in affected calves and due to multi-drug resistance, response to therapy can be poor or lead to a carrier state in recovered animals. Although enrofloxacin is labeled for treatment of bovine respiratory disease, it is not specifically labeled for treatment of Salmonella Dublin and extralabel use of fluoroquinolones in food animals is prohibited by the FDA.  Prevention of the disease is multifactorial and includes all aspects of proper neonatal calf management including adequate and timely pasteurized colostrum, maternity pen management, ventilation, sanitation and nutrition. Abuelo also discusses the use of vaccines in cows and calves to manage the disease on endemically infected farms to prevent outbreaks. Continued research on managing this disease, including the use of vaccines and improved diagnostics, will be important topics for veterinarians and producers who are managing this pathogen. REFERENCES: Frye E, Jennings C, Kremer K. Aseptic technique for blood culture collection in the field to diagnose Salmonella Dublin in calves. J Am Vet Med Assoc. 2025;263(7):1. https://doi.org/10.2460/javma.25.02.0116. PMID: 40267971. https://avmajournals.avma.org/view/journals/javma/263/7/javma.25.02.0116.xml Castro-Vargas RE, Cullens-Nobis FM, Mani R, Roberts JN, Abuelo A. Effect of dry period immunization of Salmonella Dublin latent carriers with a commercial live culture vaccine on intrauterine transmission based on the presence of precolostral antibodies in offspring. J Dairy Sci. 2024;107(12):11436-11445. https://doi.org/10.3168/jds.2024-24945The effect of Salmonella vaccination on Salmonella Dublin blood enzyme-linked immunosorbent assay results. Bov Pract. 2025;59(2), 53-60. https://doi.org/10.21423/bpj20259266 Abuelo A, Renaud D.  Salmonella Dublin Infection in Cattle. Merck Veterinary Manual. 2024. Winter A, Abuelo A, Allen DG, et al. (Eds). Merck, Rahway, NJ, USA. https://www.merckvetmanual.com/digestive-system/salmonellosis/salmonella-dublin-infection-in-cattle Salmonella Dublin Risk Management HERD SD app: https://apps.apple.com/us/app/herd-sd/id6748356498   

Nell'episodio 592 Giuliana ci parla di neutrini sterili e di un nuovo esperimento che confuta la loro esistenzaGiuliano intervista Alfonso Lucifredi che ci parla del suo libro Troppi, che ha vinto il premio GalileoValeria invece racconta di un nuovo farmaco per l'influenza che è attualmente in fase di trial clinici e del motivo per cui Merck ha recentemente acquistato l'azienda produttrice per 9.2 miliardi di dollari. Diventa un supporter di questo podcast: https://www.spreaker.com/podcast/scientificast-la-scienza-come-non-l-hai-mai-sentita--1762253/support.

On this episode Gil sits with Michael Rosenblatt, MD, one of the most accomplished physician-scientists in modern medicine. He is former Chief Medical Officer of Merck, where he led global scientific strategy and medical affairs. Previously he served as Dean of Tufts University School of Medicine, Chief Scientific Officer at Vertex Pharmaceuticals, and Professor of Medicine at Harvard Medical School, where he advanced groundbreaking research in endocrinology, metabolic bone disease, and translational science. We discuss the intersection of academia, biotechnology, pharmaceutical innovation, and the clinical science shaping modern drug development and the future of precision therapeutics.

This special episode of RealTalk MS is sponsored by EMD Serono and is only intended for a U.S. audience. EMD Serono is the healthcare business of Merck, KGaA, Darmstadt, Germany, in the United States and Canada. Please note this episode is only intended for a U.S. audience. In this special episode of RealTalk MS, Professor Elisabeth Celius and Amanda Montague join me to explore new consensus recommendations for the future of MS care from MS in the 21st Century. We'll hear what experts and people in the MS community think are the priorities to focus on to improve care and help lessen the burden of living with MS.   Professor Elisabeth Celius is a consultant neurologist with a special focus on MS at Oslo University Hospital in Norway, where she is the group leader of the MS Research Group and also conducts epidemiological, genetic, and clinical research.  Amanda Montague is a global thought leader and Interim President & CEO of the Multiple Sclerosis Association of America. Both Amanda and Elisabeth are active members of the MS in the 21st Century initiative, more commonly known as MS21. MS21 is a Merck KGaA, Darmstadt, Germany, initiative involving healthcare professionals, people with MS, and patient advocacy groups.  To learn more about MS in the 21st Century, please visit www.msinthe21stcentury.com.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we dive into a series of transformative events shaping the future of drug development, patient care, and global healthcare strategies.**Johnson & Johnson's Multiple Myeloma Advances** Johnson & Johnson has made significant strides in the treatment of multiple myeloma with their bispecific antibody, Tecvayli. In recent trials, Tecvayli has shown remarkable promise when used in combination therapies as a second-line treatment. This development is noteworthy as it could potentially challenge the dominance of CAR-T cell therapies like J&J's Carvykti by offering a more accessible and less complex alternative. For patients, this means potentially fewer logistical hurdles and a more straightforward therapeutic option, which could drastically improve patient care standards.**Regulatory Scrutiny on RSV Vaccines** Turning to regulatory news, the U.S. FDA has intensified its scrutiny of respiratory syncytial virus (RSV) vaccines developed by pharmaceutical giants such as Merck, AstraZeneca, and Sanofi for infants. This increased oversight follows reports linking some COVID-19 vaccines to adverse effects in children. The FDA's actions highlight the ongoing necessity for vigilant safety monitoring in vaccine development, especially for vulnerable populations like infants. This is a crucial step in ensuring that vaccines designed for our youngest population are both safe and effective.**Eli Lilly's Strategic Moves in Oncology and Beyond** Eli Lilly is making waves in oncology with its BTK inhibitor, Jaypirca. Despite strong phase 3 results that support its use as a first-line treatment for chronic lymphocytic leukemia (CLL), Lilly is focusing on its application as a second-line therapy. This strategic choice reflects an astute understanding of market dynamics and therapeutic niches where Jaypirca can provide substantial benefits despite competition from established first-line treatments. Additionally, Eli Lilly continues to leverage its financial success from its weight loss drug Tirzepatide to position itself as a central player in global pharmaceutical innovation. The company's strategic investments are likely to catalyze advancements across various therapeutic areas, reinforcing its role as a key contributor to medical breakthroughs.**Legislative Impact on Biopharma** In legislative news, the Biosecure Act's incorporation into the U.S. National Defense Authorization Act marks a strategic shift towards tightening regulations on Chinese biopharma entities regarding federal contracts by 2026. This move could have profound implications for international collaborations and competition within biotechnology innovation and drug development sectors. It signals a broader trend of increased scrutiny on foreign entities in sensitive industries like biopharmaceuticals.**China's Healthcare Transformation** China's healthcare landscape is undergoing significant transformation with the inclusion of drugs from companies like Pfizer, Lilly, and J&J into its first private insurance formulary. This development could enhance access to innovative medications within China, potentially improving health outcomes and influencing global pricing strategies in the pharmaceutical industry.**Gamida Cell's Milestone in Cell Therapies** In a major milestone for cell therapies, Gamida Cell has secured a second FDA approval for its stem cell therapy Omisirge. Initially approved to reduce infection risk during hematopoietic stem cell transplantations in blood cancer patients, Omisirge's expanded indication to treat severe aplastic anemia underscores the potential of cell therapies in addressing diverse hematologic conditions.**CSL Seqirus' New Facility in Australia** In Australia, CSL Seqirus has opened a $1 billion facility dedicated to producing cell-baSupport the show

In this episode of the HR Mixtape, host Shari Simpson sits down with Celeste Warren, Vice President of the Global Diversity and Inclusion Center of Excellence at Merck. They delve into the critical topic of Diversity, Equity, and Inclusion (DEI) in the workplace, emphasizing that inclusion is a shared responsibility across all levels of an organization. This conversation is particularly timely as companies navigate the complexities of employee experience and strive for inclusive leadership in a rapidly changing environment. Listener Takeaways: Learn how to foster a culture of inclusion by engaging all employees in DEI initiatives. Discover why aligning employee resource groups with business goals can drive organizational change. Explore strategies for measuring the impact of DEI efforts beyond traditional metrics. Hit “Play” to gain valuable insights on integrating DEI into your organization's fabric! Guest(s): Celeste Warren, Vice President, Global Diversity and Inclusion Center of Excellence, Merck

Andreas Munk Holm opens the episode by introducing Charles Dunn, Principal at SV Health Investors, and Ruth McKernan, CBE and Operating Partner at SV Health, former CEO of Innovate UK. SV Health is a transatlantic healthcare specialist with a focus on company creation and full-spectrum biotech investing. Notable wins include the exit of SV-created EyeBio to Merck & Co for up to $3bn including $1.3bn upfront, and the recent launch of SV's newest company creation Driag Therapeutics, a UK-based neuropsychiatry company, which recently announced its $140m Series A financing.SV Health's approach blends early-stage company creation with later-stage venture investment. Charles emphasizes that this structure allows:Diversified risk for LPs: Early-stage opportunities carry higher risk but higher upside; later-stage investments provide more stability.Learning across stages: Experience in late-stage investing informs early-stage decision-making, and vice versa.Flexible company formation: SV Health creates companies across different development stages, sometimes even after Phase 1 data exists, as with Draig Therapeutics.

What if managing your herd felt more like managing an app than wrestling with wire and posts? In this episode we'll break down how virtual fencing is reshaping grazing for livestock producers across the country. We'll explain how a simple collar and phone app let producers draw fences over any terrain, protect sensitive areas, and move herds without setting foot in the pasture. Joined by Nofence National Sales Director, Eric Yates, we dig into the rising cost and rigidity of traditional fencing, the wildlife benefits of removing physical fence, and real examples of ranchers grazing steep, rocky, flood prone country they never could have used before. He also shares how Nofence helps producers plan grazing seasons months and years ahead, monitor animals in real time, and why he believes “virtual fence trained” cattle could be the next premium in the market. About Eric Yates: Eric Yates helps ranchers unlock new opportunities with virtual fencing technology as the US National Sales Director for Nofence. He joined Nofence in June 2025 and has been at the forefront of virtual fencing since 2023. A proud 2010 graduate of Texas A&M, Eric has spent his entire career in the cattle industry including more than a decade in animal health sales with Merial and Merck, to now leading the charge in transforming grazing management for herds across the US. This episode is sponsored by Nofence. Nofence empowers livestock producers to graze without compromise while respecting tradition and embracing innovation. Built by farmers for farmers, Nofence's reliable virtual fencing system delivers peace of mind, supports sustainable livestock management, and unlocks new possibilities for the future of your operation.

JCO Editor-in-Chief Dr. Jonathan Friedberg is joined by colleagues Dr. Jennifer Woyach, Dr. Wojciech Jurczak, and Dr. Matthew Davids to discuss simultaneous publications presented at ASH 2025 on pertibrutinib, a new upfront treatment option for patients with chronic lymphocytic leukemia. TRANSCRIPT The disclosures for guests on this podcast can be found in the show notes. Dr. Jonathan Friedberg: I'm Jonathan Friedberg, editor of Journal of Clinical Oncology, and welcome to JCO After Hours, where we are covering two manuscripts that were presented at the American Society of Hematology meeting 2025 in Orlando, Florida. I am delighted to be joined by colleagues on this call to discuss these pivotal manuscripts which cover the topic of pirtobrutinib, a new upfront treatment option for patients with chronic lymphocytic leukemia. I will first just introduce our guests, Dr. Woyach. Dr. Jennifer Woyach: Hi, my name is Jennifer Woyach. I am from the Ohio State University. Dr. Wojciech Jurczak: Hello, I am Wojciech Jurczak, working at the National Research Institute of Oncology in Krakow, Poland. Dr. Matthew Davids: Hi, I am Matthew Davids from Dana-Farber Cancer Institute in Boston. Dr. Jonathan Friedberg: We are going to start by just learning a little bit about these two trials that were both large, randomized phase 3 studies that I think answered some definitive questions. We will start with your study, Jennifer. If you could just describe the design of your study and the patient population. Dr. Jennifer Woyach: Absolutely. So this is the BRUIN CLL-314 study, and this is a phase 3 randomized trial of pirtobrutinib versus ibrutinib in patients with CLL or SLL who had not previously been treated with a covalent BTK inhibitor. The patients were both treatment-naive and relapsed/refractory, about one-third of the patients treatment-naive, the rest relapsed/refractory, and they were stratified based upon 17p deletion and the number of prior lines of therapy. The primary objective was looking at non-inferiority of overall response rate over the entire treated population as well as the relapsed/refractory patient population. Key secondary objectives included progression-free survival in the intention-to-treat and the smaller relapsed/refractory and treatment-naive populations. Dr. Jonathan Friedberg: And just comment a little bit on the risk of the patients. Dr. Jennifer Woyach: This study was fairly typical of this cohort of patients. Within the relapsed/refractory patient population, there was a median of one prior line of therapy in each of the groups, up to nine prior lines of therapy in the patients included on the study. For the overall cohort, about two-thirds of the patients were IGHV unmutated, about 15% had 17p deletion, 30% had TP53 mutations, and about 35% to 40% had a complex karyotype, which is three or more abnormalities. Dr. Jonathan Friedberg: And what were your findings? Dr. Jennifer Woyach: Regarding the primary outcome, which is the focus of the publication, we did find that pirtobrutinib was indeed non-inferior and actually superior to ibrutinib for overall response rate throughout the entire patient population and in both the relapsed/refractory and treatment-naive cohorts. PFS is a little bit immature at this time but is trending towards also being significantly better in pirtobrutinib-treated patients compared with ibrutinib-treated patients. Probably most significantly, we found this to be the case in the treatment-naive cohort where there was a striking trend to an advantage of pirtobrutinib versus ibrutinib. Dr. Jonathan Friedberg: And the follow-up that you have on that progression-free survival? Dr. Jennifer Woyach: So we have about 18 months follow-up on progression-free survival. Dr. Jonathan Friedberg: The second study, Wojciech, can you just go through the design and patient population that you treated? Dr. Wojciech Jurczak: Thank you, Dr. Friedberg, for this question. So the BRUIN CLL-313 study was, in fact, the first phase 3 study with pirtobrutinib in exclusively untreated CLL patients. It was a randomized study where we challenged pirtobrutinib versus bendamustine-rituximab. At the time we designed the protocol, bendamustine-rituximab was an option as a standard of care, and Bruton tyrosine kinase monotherapy was used far more commonly than nowadays. The primary target of the study was progression-free survival. We took all untreated patients except for those with 17p deletions. Therefore, it is a good representation for intermediate risk. We had about 60% of the population, 56 to be precise, which was unmutated, evenly distributed into two treatment arms. 17p deleted cases were excluded, but we had about 7% and 8% of TP53 mutated patients as well as about 11% and 7%, respectively, in the pirtobrutinib and bendamustine-rituximab arm of patients with complex karyotype. The progression-free survival was in favor of pirtobrutinib and was assessed by an independent review committee. What is important is that the progression-free survival of the bendamustine-rituximab arm was actually similar to the other studies addressing the same questions, like the comparison with ibrutinib in the ALLIANCE study or zanubrutinib in the SEQUOIA study. What was different was the hazard ratio. In our study, it was 0.20. It was one of the longest effect sizes noted in the frontline BTK study. It represented an 80% reduction in progression-free survival or death. If we compare it to ibrutinib or zanubrutinib, it was 0.39 and 0.42 respectively. Presumably, this great effect contributed towards a trend of overall survival difference. Although survival data are not mature enough, there is a clear trend represented by three patients we lost in the pirtobrutinib arm versus 10 patients lost in the bendamustine-rituximab arm. This trend in overall survival is becoming statistically significant despite the fact that there was a possibility of crossover, and effectively 52.9 patients, which means 18 out of 34 patients relapsing in the bendamustine-rituximab arm, were treated by pirtobrutinib. Dr. Jonathan Friedberg: I am going to turn it over to Matt. The question is: why study pirtobrutinib in this patient population? And then with these two studies, how do you find the patients that were treated, are they representative of people who you see? And do you see this maybe being approved and more widely available? Dr. Matthew Davids: I think in terms of the first question, why study this in a frontline population, we have seen very impressive data with pirtobrutinib in a very difficult-to-treat population of CLL patients. This was from the original BRUIN phase 1/2 study where most of the patients had at least two or three lines of therapy, often both a covalent BTK inhibitor and the BCL2 inhibitor venetoclax, and yet they were still responding to pirtobrutinib. The drug was also very well tolerated in that early phase experience. And actually, we have seen phase 3 data from the BRUIN 321 study comparing pirtobrutinib to bendamustine and rituximab in a relapse population as well. So I think that really motivated these studies to look at pirtobrutinib as a first therapy. You know, often in other cancers of course, we want to use our best therapy first, and I think these studies are an initial step at looking at that. In terms of the second question around the patient population, these are pretty representative patient populations, I would say, for most frontline CLL studies. We see patients who are a bit younger and fitter than sort of the general population of CLL patients who are treated in clinical practice, and I think that is true here as well. Median age in the sort of mid-60s here is a bit younger than the typical patients we are treating in practice. But that is not different from other CLL frontline studies that we have seen recently, so I think it makes it a little bit easier as we kind of think across studies to feel comfortable that these are relatively similar populations. Dr. Jonathan Friedberg: How do you see this either getting regulatory approval or potentially being used compared to current standard of care options? Dr. Matthew Davids: So my understanding is that both of these trials were designed with registrational intent in the frontline setting, and they are both positive studies. That is certainly very encouraging in terms of the potential for an approval here. We have seen in terms of the FDA recently some concerns around the proportion of patients who are coming from North America, and my understanding is that is relatively low on these two studies. But nonetheless, the datasets are very impressive, and so I think it is certainly supportive of regulatory approval for frontline pirtobrutinib. Dr. Jonathan Friedberg: I will ask Jennifer a question. The control arm in your study was ibrutinib, and I think many in the audience may recognize that newer, second-generation BTK inhibitors like acalabrutinib and zanubrutinib are more frequently used now if monotherapy is decided. How do you respond to that, and how would you put your results in your pirtobrutinib arm in context with what has been observed with those agents? Dr. Jennifer Woyach: Yeah, that is a great question. Even though in the United States we are predominantly using acalabrutinib or zanubrutinib when choosing a monotherapy BTK inhibitor, this is actually not the case throughout the entire world where ibrutinib is still used very frequently. The head-to-head studies of both acalabrutinib and zanubrutinib compared to ibrutinib have shown us pretty well what the safety profile and efficacy profile of the second-generation BTK inhibitors is. So even though we do not have a head-to-head study of acalabrutinib or zanubrutinib versus pirtobrutinib, I think, given the entirety of data that we have with all of the covalent BTK inhibitors, I think we can safely look at the pirtobrutinib arm here, how the ibrutinib arm compares or performs in context with those other clinical trials. And though we really can not say anything about pirtobrutinib versus acalabrutinib or zanubrutinib, I think we can still get a good idea of what might be the clinical scenarios in which you might want to choose pirtobrutinib. Dr. Jonathan Friedberg: And Wojciech, do you agree with that? Obviously, I think you have acknowledged that chemoimmunotherapy is rarely used anymore as part of upfront treatment for CLL. So, I guess a similar question. If you were to put the pirtobrutinib result in your study in context with, I guess, more contemporary type controls, would you agree that it is competitive? Dr. Wojciech Jurczak: Well, I think that that was the last study ever where bendamustine-rituximab was used as a comparator arm. So we should notice that smashing difference. Because if we look at the progression-free survival at two years, we have 93.4% in pirtobrutinib arm versus 70.7% in bendamustine-rituximab arm. Bendamustine-rituximab arm did the same as in the other trials, like ALLIANCE or SEQUOIA. Pirtobrutinib did exceptionally well, as pirto is not just the very best BTK inhibitor overcoming the resistance, but perhaps even more important for the first line, it is very well tolerated and is a very selective drug. Now, if we look at treatment-related adverse events, the discontinuation rate, they were hardly ever seen. If we compared the adverse events in exposure-adjusted incidence, literally all adverse events were two or three times higher in bendamustine-rituximab arm except for the bleeding tendency, which however was predominantly in CTCAE grade 1 and 2 with just 0.7% of grade 3 hemorrhage. Therefore, I think that we should actually put the best and the safest drugs upfront if we may, and pirtobrutinib is, or should be, the first choice if we choose monotherapy. Now, I understand that we are not presenting you the data of pirtobrutinib in combination with anti-CD20 or with BCL2 inhibitors, but that is to come. Dr. Jonathan Friedberg: Matt, how would you envision, were regulatory approval granted and this were an option, using this in the upfront patient population? Is there anybody who you would preferentially use this or start on this treatment? Or would this be something that you would tend to reserve for second line? Dr. Matthew Davids: So I would say that in general for most of my patients who would want to start with a continuous BTK inhibitor, I would still use a covalent BTK inhibitor, and I say that for a couple of reasons despite the very promising data from these studies. The first is that the follow-up for both of these phase 3 trials is still quite short, in the range of a median 18 to 24 months. And we know that CLL is a marathon, not a sprint, and these patients are going to probably be living for a very long time. And we do have much longer follow-up from the covalent BTK inhibitors, median of 10-year follow-up with ibrutinib and five to six years with zanubrutinib and acalabrutinib respectively. And you know, I do not think that the pirtobrutinib is going to fall off a cliff after two years, but on the other hand, I think there is a lot of value to long-term data in this disease, and that is why I think for most of my patients I would stick with covalent BTK inhibitors. But the other important factor that we need to consider is patients who are younger and may have many different CLL treatments over the years. We have to be very careful, I think, about how we sequence these drugs. We know right now that we can start with covalent BTK inhibitors and then subsequently patients will respond well to the non-covalent inhibitor pirtobrutinib in later lines of therapy. But right now we do not have prospective data the other way around. So how will the patients on these studies who progress on pirtobrutinib respond to covalent BTK inhibitors? We do not know yet. There have not been a lot of progression events, which is great, but we would like to see some data in that respect to feel more comfortable with that sequence. Now, I do think that particularly for older patients and those who have significant cardiovascular comorbidities, if they wanted to go on a continuous BTK inhibitor, I do think these data really strongly support using pirtobrutinib as the BTK inhibitor of choice in that population. In particular, the cardiovascular risks with pirtobrutinib seem to be quite low. I was very struck in the comparison with BR that the rate of AFib was equivalent between the two arms of the study. And that is really the first time we have seen that with any of these BTK inhibitors, no elevated risk of AFib in a randomized study. I think that is the population where it will get the most traction first, is the upfront, sort of older patient with significant cardiovascular comorbidities. And as the data from these studies mature, I think that we will start to see more widespread use of pirtobrutinib in the frontline setting. Dr. Jonathan Friedberg: Jennifer, I am just curious if you have any personal experience or heard anecdotally about after progression on pirtobrutinib the use of other BTK inhibitors and whether there is a growing experience there. Dr. Jennifer Woyach: I do not think that there is much clinical experience, you know, as Matt alluded to, it certainly has not been tested yet. There has been some data in relapsed CLL suggesting that in people who have resistance mutations to covalent BTK inhibitors after treatment with pirtobrutinib, sometimes those mutations go away. I think most of us are concerned that they are probably not actually gone but maybe in compartments that we just have not sampled, suggesting that sort of approach where you might sequence a covalent inhibitor after a non-covalent in somebody who had already been resistant probably would not work that well. But, you know, in this setting where people had never been exposed to a covalent BTK inhibitor before, we really have no idea what the resistance patterns are going to be like. We assume they will be the same as what we have seen in relapsed CLL, but I think we just need some longer follow-up to know for sure. Dr. Wojciech Jurczak: If I may confront Dr. Davids about the use of covalent BTK inhibitors upfront, well, I think that we should abandon the idea of using the first and the second and the third generation, at least if we don't have medical lines. If we endlessly block the same pathway, it is not going to be effective. So if pirtobrutinib gets approval in first, second line, we do not necessarily have to use it in the first line. I am not here in a position to defend that we should treat patients with pirtobrutinib upfront and not BCL2 time-limited regimen. However, the way I look at CLL patients when choosing therapy is not just how should I treat them now, but what would be the best regimen in 5, 10 years if I have to re-treat them. And in some instances, the idea may be that in this setting we would like to have a BTK inhibitor upfront to have a BCL2 inhibitor later to make it time-limited. Although I understand and I agree with Matthew that if we have an elderly, fragile population, then the charm of having a drug taken once a day in a tablet with literally few cardiovascular adverse events might be an option. Dr. Jonathan Friedberg: And I will give Matt the last word whether he wants to respond to that, and also just as a forward-looking issue, I know both investigators have implied that there will be future studies looking at combinations with pirtobrutinib, and if you have any sense as to what you would be looking for there. Dr. Matthew Davids: The field really is heading toward time-limited therapy for most patients, I would say. There is a bit of a discrepancy right now in the field between sort of what we are doing in academic practice and what is done sort of more widely in community practice. And so right now we are going to see evolving datasets comparing these approaches. We are already seeing data now from the CLL17 study with ibrutinib comparing continuous to time-limited venetoclax-based therapy, and we are seeing similar efficacy benefits from these time-limited therapies without the need for continuous treatment. And so that is where I think some of the future studies with pirtobrutinib combining it with venetoclax and other partners are so important. Fortunately, several of these studies are already ongoing, including a phase 3 trial called CLL18, which is looking at pirtobrutinib with venetoclax, comparing that to venetoclax and obinutuzumab. So I am optimistic that we are going to be developing these very robust datasets where we can actually use pirtobrutinib in the frontline setting as a time-limited therapy as a component of a multi-drug regimen. So far, those early data are very promising. Dr. Wojciech Jurczak: Perhaps last but not least, in a single center we have treated over 300 patients with pirtobrutinib. So eventually some of them relapsed. And I must say that our experience on BCL2 inhibitors, not just venetoclax but including sonrotoclax, are appealingly good. Therefore, by using pirtobrutinib even earlier, we do not block the efficacy of other compounds. Dr. Jonathan Friedberg: All right. Well, I want to thank all of our speakers. I also want to congratulate our two guests who presented these very influential papers at the ASH Annual Meeting, and chose to publish them in JCO, so we thank you for that, and Dr. Davids for your commentary - really appreciated. That is this episode of JCO After Hours. Thank you for your attention. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Disclosures Dr. Wojciech Jurczak Consulting or Advisory Role: BeiGene, Lilly, Abbvie/Genentech, Takeda, Roche, AstraZeneca Research Funding: Roche, Takeda, Janssen-Cilag, BeiGene, AstraZeneca, Lilly, Abbvie/Genentech Dr. Jennifer Woyach Consulting or Advisory Role: Pharmacyclics, Janssen, AstraZeneca, Beigene, Loxo, Newave Pharmaceutical, Genentech, Abbvie, Merck Research Funding: Company name: Janssen, Schrodinger, beone, Abbvie, Merck, Loxo/Lilly Dr. Matthew Davids Honoraria: Curio Science, Aptitude Health, Bio Ascend, PlatformQ Health, Plexus Consulting or Advisory Role: Genentech, Janssen, Abbvie, AstraZeneca, Adaptive Biotechnologies, Ascentage Pharma, BeiGene, Lilly, Bristol-Myers Squibb, Genmab, Merck, MEI Pharma, Nuvalent, Inc., Galapagos NV, Schroedinger Research Funding: Ascentage Pharma, Novartis, MEI Pharma, AstraZeneca  

Dr. Pedro Barata and Dr. Ravin Garg discuss strategies to increase trial representation, including leveraging trial navigators and prioritizing pragmatic trial models, as featured in the ASCO Educational Book article, "Practical Guide to Clinical Trial Accessibility: Making Trial Participation a Standard of Care." TRANSCRIPT Dr. Pedro Barata: Hello, and welcome to By the Book, a podcast from ASCO featuring compelling perspectives from authors and editors of the ASCO Educational Book. I'm Dr. Pedro Barata. I am a medical oncologist at University Hospital Seidman Cancer Center and an associate professor of medicine at Case Western Reserve University in Cleveland, Ohio. I am also the associate editor of the ASCO Educational Book. We know that in recent years, the oncology community has increasingly prioritized the need to modernize clinical trial eligibility, reduce patient burden, and enhance diversity in trial participation. On that note, today we will be speaking about ways to enhance access to clinical trials with Dr. Ravin Garg. He is a hematologist oncologist at Maryland Oncology Hematology and also an assistant professor of oncology at Johns Hopkins Hospital in Baltimore. Dr. Garg is also the co-author of a fantastic paper in the ASCO Educational Book titled, "Practical Guide to Clinical Trial Accessibility: Making Trial Participation a Standard of Care."  Dr. Garg, welcome. Thanks for being here, and congrats on your paper. Dr. Ravin Garg: Thank you for having me, Pedro. I am excited to be here. Dr. Pedro Barata: [KI1]  Your paper is a wonderful, multidisciplinary piece that actually features perspectives from the different stakeholders, right? The patient advocacy, industry, community practice, and academia about these challenges in making trials more available. This podcast is a wonderful platform. It reaches out to a lot of folks within our community. So, I will start by asking you the obvious. Why do you think it is a must read for our community, for our listeners? Dr. Ravin Garg: So Pedro, thanks again for inviting me. You do a great job with these podcasts.  So, I think first and foremost, oncologists right now are under a lot of stress, just in terms of clinical volume. There is concern for research money, and how we get the best care for our patients. So I think this article is very important because it helps bring together, as you had mentioned, the stakeholders throughout academic to community practice and everywhere in between, and try to find how, as a team with different oncologists who partake in different aspects of oncology, can come together to streamline the process to try to get our patients on trials, or certainly have them have availability of trials, just if they are interested in going on them. Being in practice, we have had several challenges that we can talk about throughout this podcast, but I think it is a very important paper because it recognizes that at the end of the day, it takes a team effort for all of us in academics, community, industry, and pharmaceuticals to really come together as a team to really help put forth the trials for our patients. Dr. Pedro Barata: So, from the perspective of a community oncologist, how do you put together, or maybe you can describe some of the challenges that you see to increase trial participation in the community? Dr. Ravin Garg: Yes, Pedro, that is a great question, and it is something that I keep on thinking about and trying to find ways to be better at it myself. But I will say some of the challenges as a community doctor that I have seen for myself and talking to other colleagues. Number one, I do think there is a lot of stress on doctors in the community in general, Pedro. Oftentimes we are tasked to see a wide smorgasbord of patients, so we may not have the luxury of being a specialist in any particular tumor subtype. Like oftentimes, we will have to see lung cancer, the next one will be breast cancer, the next one could be CML, the next one could be thrombocytopenia. And as you know better than I do, Pedro, the field in each one of these disciplines is changing so rapidly: molecular genomics, radioligand treatments, different imaging tests, MRD testing for some of our hematologic malignancies. And I think one challenge we have in community is just keeping up with the basics of Oncology 101. In the process of doing that, it can be very difficult to sometimes remember that we have very exciting trials available for our patients. So, I think a lot of it is the day in and day out of being an oncologist is so taxing at times that oftentimes a research trial is not the first thing in our head space when we see a patient. I think number two, Pedro, at least in the community, and perhaps this is with academics too, is that we are bombarded, I would say, by a lot of messaging these days. We have in-baskets to go through, labs to go through, things of that nature. And in the process of a patient visit, seeing them, doing an exam, taking a history, trying to go over the NCCN guidelines on best practice for how to manage their care, at least for me at times, it is very hard to remember, "Hey, there might be a great trial available, whether within our network or maybe partnering with an academic center." So getting through a day can be fraught with a lot of peril and just difficulties, I would say. And I would say number three, Pedro, at least as, you know, I am in a private practice where I do see a wide range of benign and malignant hematology and solid tumors, so I would not call myself a specialist. And I think the challenge with that, at least for trials, Pedro, is that when you are a specialist or perhaps you are focusing on a couple of disease subtypes, you become more of an authoritative voice in those types of tumors, and you might be more aware of the trials within your network or perhaps in proxy with an academic center that you can offer your patient. So I think when sometimes we spread ourselves too thin, it can be very hard to be a thought leader, if you will, in a particular subtype of a malignancy, let's say, and maybe not be aware of a trial that could be really well-suited for your patient. In terms of ideas that myself and colleagues have had in terms of helping mitigate against some of these, I would say, setbacks or issues in the practice for trial enrollment, some of the things we have talked about, Pedro, is, number one, is we do partner with academic centers. So we live here in Maryland. We have several really fantastic academic centers. So, you know, oftentimes, not just within our practice of Maryland Oncology Hematology, we have a lot of great trials available here too, for certain, but in addition to that, we will often times work with doctors at Georgetown, Johns Hopkins, and Maryland if they have a compelling trial that we do not have within our network. It is really of the patient's interest, Pedro, to reach out to them in a collaborative manner to see if they have a trial that might be really compelling for your patient. So I do find myself collaborating a lot with colleagues in, like talented like yourself in academics. You know, I think you do a lot of GU malignancies. So as an example, like partnering with colleagues who are GU experts and say, "Hey, we have a patient with stage IV renal cell. These are the standard options I know, but are there any trials that you might have available?" I think the other thing that has been very helpful for us is having navigators within research, Pedro. Like as an example, what has really helped the uptake of trial enrollment for our center in Annapolis is having a research navigator because often times what they can do is, a priori, Pedro, before you see the patient and you are kind of formulating a standard of care treatment plan perhaps, they might tug you on the shirt and say, "Hey, we have a great trial here through Sarah Cannon, or there might be something else out there." And being aware of that when you go into a patient's room really provides a nice arena, if you will, to go and say, "The standard of care is here, but hey, we have a trial option that might be well suited for you, maybe perhaps even better, that we can talk about, too." So having research support in the community is really a huge boon, I think, Pedro, for us to really increase our enrollment for patients onto trials. Dr. Pedro Barata: Yes, I really love that, Ravin. So, let me switch gears a bit. I would love for you to talk a little bit about patient advocacy because they do play a huge role in cancer, and they address many barriers. How do you think we should leverage the patient advocacy groups to reduce patient burden and maybe have them really leverage patient advocacies to improve representation in clinical trials? What do we think we can do more? Dr. Ravin Garg: Oh, Pedro, I think they are very critically important. As a clinical oncologist now, and I would say this is for anyone in the field of medicine, you are exactly right. I think patients are bombarded by information. There are a lot of things online, whether it be TikTok, Facebook, Google, Yahoo, and people really just have a lot of information given to them. And some of it is fact driven, and some of it is not, Pedro. And oftentimes, I do think there can be at times a mistrust with some medical personnel. I think we are in an era where we are seeing that to some degree with some attributes of medicine. And I think of it as an opportunity for education for the patient and for myself as a physician. And I think patient advocates, to your point, which was well taken, serve as a bridge to both. And what I mean is that, you know, patient advocates are wonderful. They are, I think, outstanding communicators. They almost are a neutral party, Pedro, where many patients feel that they are an independent source of information that is free of bias, if you will. They are there to provide support, emotional support, scientific support for patients so they can make an informed decision. So, in terms of our practice right now, patient advocates is something that we are evolving in that capacity, I would say, Pedro. I think now more than ever, having more people as bridges of communication with care providers along with patients is of critical importance. And I would venture a guess, and I think this has been published, where patient advocates really can help tremendously in familiarizing patients with trials and what they are all about and maybe clear up some misconceptions of what trials, what the mission of trials are. Because I do think some patients, at least I have had a few over the years, where when they hear the term trial, they almost think they are being experimented upon, when, in point of fact, they could really help advance their care. That messaging along the way for some can may be mixed up a little bit. And so I think patient advocates is a really great way to offer more information for patients with a source they find very independent and trustworthy, if you will. And it can really help expedite, and I think make a more fruitful conversation for care providers, whether academic or community, and they might be more open-minded in terms of enrolling onto a trial. Dr. Pedro Barata: Wonderful. Yes, I agree. I agree with you completely.  So let's focus a little bit now on the folks designing the studies. We usually call them the sponsors. It might be an academic sponsorship, if you will, but we can also have pharma being the sponsor of a study. The angle from an academic design, it is not necessarily the same as what happens when we have pharma. And from that angle, how do you think a more inclusive research can be promoted? Dr. Ravin Garg: Oftentimes with trials, I think keeping them simple, as simple as we can. And what I mean by that is, often times for trials, Pedro, even for care providers who are enrolling, it can be daunting when there are a lot of different things involved, particularly, let's say, for investigator sponsored, which are incredibly brilliant science, incredible, but it can be a little bit daunting for patients and even the referring physician to talk about getting translational specimens, imaging, traveling to certain centers to get scans and biopsies and even different diagnostic testing like PSMA testing for, you know, prostate cancer. And it can, I think, be very intimidating for patients in terms of what might be required of him or her to enter onto a trial. Like, "This is not what I signed up for. This is laborious. This is a full time job for me. Do I have to pay for parking to go to a city? Do I have to pay for these imaging tests? And do I have to stay in a place for my family to enroll onto a trial?" So I think keeping trials as simple as possible, but yet cull the data we need as investigators where we can really advance the care, hopefully get approval for a drug, but also learn more about the medication and how it works for our patients. So I think simplifying language for trial is very important. I know when I have gone over studies for patients, Pedro, if it is a voluminous amount of information, they can right away get very intimidated. "Like, oh my goodness, this is like a term paper for college again," you know? I am joking, but you know, keeping language simplified is very important, I think, number one. And I feel that sometimes when they are asked to do a lot of different diagnostic testing, which is very important for translational work, I 100% understand, but I do think sometimes patients can get a little bit off put, if you will, and frustrated with the whole process of doing it. The second thing for our patients, Pedro, that they have mentioned to us when we put them on trials, not just within our own site but elsewhere, is that it takes a lot of time in terms of collecting information, perhaps a washout period from their last standard of treatment prior to enrollment onto a study. Many patients, Pedro, as you know better than I do, are in maybe crisis in terms of their health and their cancer might be growing, promulgating out of control, and they worry about not being able to expeditiously start onto a treatment, onto a trial. So that can lead to a lot of frustration. And one thing that you brought up, which was outstanding for me, is the enrollment criterion for some of our patients is felt to be somewhat strict. We have had some patients who may have had a remote history of a stage I malignancy that was by all accounts in remission, you know, let's say 4 or 5 years in the past, and the risk of recurrence at this point would be incredibly low, but they may not be able to enter onto a study because of some stringent criterion put forth. And that can be a little bit frustrating. In fact, I have had one or two patients who, as an example, with kidney issues, but the GFR was about 60, like right near a cutoff that oftentimes, as you know, we use where you can get into trial or not. And you know, if they are at 58, as an example, and otherwise they are a picture of health, a great candidate for a trial that will likely advance their care, and if the entry criterion is too stringent, that might be a lost opportunity for all parties involved, all stakeholders, if you will. I do appreciate the criterion for entry onto studies cannot be too liberalized. You have to have a certain baseline, but there is a little bit of a gray area and tension, of sorts, if you will, where the patient has a comorbid illness that is a disqualifying offense, but in practicality, perhaps it shouldn't be, especially if they are motivated and there is an opportunity to really advance their care. We have run into, not often, but sometimes in the past, I should say, where patients have been very off put because we try to get them onto a study and there may have been a particular feature or attribute in their underlying care that they couldn't get onto it. So I think having a little bit more thoughtfulness, perhaps, in terms of entry criterion and practicality, if you will, I think would really help enrollment onto studies. Dr. Pedro Barata: Really well said. Is there anything else that you would like to tell our listeners before we wrap up the podcast today? Dr. Ravin Garg: I would say just macroscopically speaking, it is really an honor to be an oncologist. I think I speak for both of us. Anyone listening who is thinking about the field, it is tremendous. Just the research, the bravery of our patients, and the thoughtfulness of our scientists like Pedro and translationalists and clinical trialists is really awe inspiring. So I have really loved this field. I will say from a trial perspective, we really need to enter as many patients as we can onto trials because the science is so brilliant now, the genomic underpinnings of the tumor, we are making great strides as a team of clinicians and scientists, translationalists. So the more that we can get people onto trials and get approved drugs, it is going to help them out in the end. So I think it is such an important time for all of us to come together as a community, find the best way to help our patients out. And clinical trials have to be at the forefront of how we can continue to advance care for our patients. Dr. Pedro Barata: Yeah, no Ravin, I really agree with you. We really need to increase access to clinical studies, and actually your paper is a great step in that direction by raising awareness, bringing up solutions, and again, collaboration, collaboration, collaboration is really a multidisciplinary effort to accomplish that.  Thank you so much for sharing your fantastic thoughts and insights with us. Dr. Ravin Garg: Thank you, Pedro. I am- you do a wonderful job with these podcasts. I am really honored to meet you and to be part of this. Dr. Pedro Barata: And thank you to our listeners for your time today. I encourage you to check out Dr. Garg's article in the 2025 ASCO Educational Book. We will post a link to the paper in our show notes. And please join us again next month on By the Book for more insights on key advances and innovations that are shaping modern oncology. Thank you for your attention. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:          Dr. Pedro Barata   @PBarataMD    Dr. Ravin Garg Follow ASCO on social media:          @ASCO on X      ASCO on Bluesky     ASCO on Facebook       ASCO on LinkedIn       Disclosures:       Dr. Pedro Barata:   Stock and Other Ownership Interests: Luminate Medical   Honoraria: UroToday   Consulting or Advisory Role: Bayer, BMS, Pfizer, EMD Serono, Eisai, Caris Life Sciences, AstraZeneca, Exelixis, AVEO, Merck, Ipson, Astellas Medivation, Novartis, Dendreon   Speakers' Bureau: AstraZeneca, Merck, Caris Life Sciences, Bayer, Pfizer/Astellas   Research Funding (Inst.): Exelixis, Blue Earth, AVEO, Pfizer, Merck    Dr. Ravin Garg: Patents, Royalties, Other Intellectual Property: Creator, editor, and writer of hemeoncquestions.com  

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we dive into a series of pivotal events shaping the landscape of drug development and patient care. The interplay between scientific advancements, regulatory shifts, and strategic partnerships is setting the stage for significant transformations within the industry.A highlight of recent developments is the legal challenge faced by Merck & Co. regarding its new subcutaneous version of Keytruda. This immunotherapy, already a breakthrough in cancer treatment, has encountered a hurdle in Germany where Halozyme, known for its drug-delivery technologies, has secured a preliminary injunction. This move by a German court halts Merck's activities related to Keytruda SC in Germany and underscores the intricate web of intellectual property rights in drug launches across international markets. The outcome of this case could establish crucial precedents for future commercialization efforts involving advanced drug delivery technologies.Meanwhile, there's promising news from Bristol Myers Squibb as their CAR-T therapy, Breyanzi, receives its fifth FDA approval, this time for marginal zone lymphoma. This approval is particularly noteworthy as it marks Breyanzi as the first CAR-T treatment sanctioned for this specific indication and extends its use across five different types of blood cancers. CAR-T therapies continue to represent a frontier in cancer treatment by leveraging the body's immune system to combat malignancies more effectively. This success story from Bristol Myers Squibb highlights the expanding potential of CAR-T therapies in tackling various hematological cancers, offering renewed hope for patients with limited treatment avenues.On the regulatory front, the FDA's proposal to consider single-trial approvals for certain drugs has sparked considerable debate. While some industry voices express concerns about potential compromises to safety and efficacy standards, others see it as an opportunity to invigorate research and development investments by reducing both time and costs associated with bringing new therapies to market. This shift could indeed accelerate innovation but will necessitate a careful balance to uphold rigorous safety standards.In parallel regulatory news, Daiichi Sankyo has received an "untitled letter" from the FDA over its patient ambassador video for Turalio, indicating ongoing challenges in navigating drug promotion guidelines and patient engagement strategies. Such interactions emphasize the complexities pharmaceutical companies face within regulatory frameworks.Shifting focus to corporate strategies, Mark Cuban's Cost Plus Drugs is exploring a partnership with Humana aimed at addressing prescription drug costs for employers. This collaboration seeks to reduce healthcare expenses through innovative pricing models and distribution channels, reflecting a broader industry trend toward cost containment and value-based care delivery.In another development affecting public health policy, the CDC's Advisory Committee on Immunization Practices has postponed its vote on changes to newborn hepatitis B vaccine policies due to ongoing debates and confusion surrounding the topic. This delay highlights the intricate nature of updating long-standing public health policies, especially those impacting vaccination schedules.From an investment perspective, Freenome's decision to go public through a $330 million SPAC deal stands out. Specializing in developing blood tests for early cancer detection using machine learning technologies, Freenome's move aims to secure capital necessary for advancing its diagnostic tools—potentially transforming cancer screening practices by enabling earlier detection and intervention.In clinical trial news, Praxis Precision Medicines reported positive efficacy results from a Phase 2 trialSupport the show

I detta faktaspäckade avsnitt gästas vi av Erik Iwarsson, läkare inom klinisk genetik, för att reda ut begreppen kring ett ämne som blir alltmer aktuellt: genetisk testning. Vad är egentligen skillnaden på att testa embryon för ärftliga sjukdomar (PGT-M/SR) och att screena för kromosomavvikelser (PGT-A)? Vi dyker ner i varför PGT-A inte är tillåtet i Sverige idag och vad den nya SBU-rapporten säger om metodens effekt på "time to pregnancy". Erik förklarar även genetiken bakom upprepade missfall, hur NIPT-test fungerar och de etiska frågorna kring att screena donatorer. Ett otroligt lärorikt samtal som ger en djupare förståelse för både de medicinska möjligheterna och de svåra avvägningarna inom IVF-vården. Erik Iwarsson  är Docent i Medicinsk genetik vid Karolinska Institutet och överläkare vid Klinisk genetik, Karolinska Universitetssjukhuset. Avsnittet görs i samarbete med Merck. Ladda gärna ner deras patientbroschyrer via länken på Mercks Instagram "fertilitetsträdet" för mer kunskap.

El experto de Operativa Dax analiza los títulos de JP Morgan, Oracle, Catepillar, Merck y CaixaBank, entre otros

Big tech is stumbling while pharma stocks surge, what does that mean for markets heading into 2026? In this episode, Anthony and Piers unpack why Nvidia, Microsoft, and Amazon are dragging, while Eli Lilly and Merck lead a surprising rotation. They also explore shifting Fed rate cut expectations, conflicting US labor data, and what it all signals for the S&P 500's next move.We also break down Deutsche Bank's “triple whammy” dollar call, Trump's Fed chair pick, and why a yen carry trade unwind could shake crypto markets. Plus, UK PMI surprises and pound strength, are brighter days ahead for the UK economy? Tune in for easy-to-follow macro insights this week!(00:00) Topics & Listener Shoutouts(02:51) Big Tech Wobble, Pharma Surge(09:16) Fed Cut Expectations & Labour Data(18:27) Trump's Fed Pick & Market Reaction(24:23) Deutsche Bank US Dollar Call(30:07) Yen Carry Trade & Crypto Risk(36:01) UK Budget Bounce & PMI Surprise*****Last chance to join our in-person Finance Bootcamp in London 15-19 December 2025. As part of our podcast community, you can use the code BOOT500 at checkout for a £500 discount.

Dr. Monty Pal and Dr. Jason Westin discuss the federal funding climate for cancer research and the persistent problem of drug shortages, two of the major concerns facing the oncology community in 2026. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I am your host, Dr. Monty Pal. I am a medical oncologist and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. There are always multiple challenges facing oncologists, and today, we discuss two of them that really stand out for 2026: threats to federal funding for cancer research and the persistent problem of drug shortages. I am thrilled to welcome Dr. Jason Westin, who believes that one way to meet these challenges is to get oncologists more involved in advocacy, and he will share some strategies to help us meet this moment in oncology. Dr. Westin is a professor in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center, but he actually wears a lot of hats within ASCO. He is a member of the Board of Directors and has also previously served as chair of ASCO's Government Relations Committee. And he is also one of the inaugural members of ASCO's Political Action Committee, or PAC. He has testified before Congress about drug shortages and many other issues. Dr. Westin, I am really excited to have you on the podcast today and dive into some of these elements that will really impact our community in 2026. Thanks so much for joining us today. Dr. Jason Westin: Thank you for having me. Dr. Monty Pal: You've had such a range of experience. I already alluded to you testifying before Congress. You've actually run for office before. You wear so many different hats. I'm used to checking my PubMed every other day and seeing a new paper out from you and your group, and you publish in the New England Journal [of Medicine] on practice-setting standards and the diseases that you treat. But you've also done all this work in the domain of advocacy. I can't imagine that balancing that is easy. What has sort of motivated you on the advocacy front? Dr. Jason Westin: Advocacy to me is another way to apply our skills and help more people than just those that you're sitting across from at the time. Clinical research, of course, is a tool to try and take what we know and apply it more broadly to people that you'll never meet. And advocacy, I think, can do the same thing, where you can have a conversation with a lawmaker, you can advocate for a position, and that hopefully will help thousands or maybe even more people down the road who you'd never get to directly interact with. And so, I think it's a force multiplier in the same way that research can be. And so, I think advocacy is a wonderful part of how doctors care for our patients. And it's something that is often difficult to know where to start, but once people get into advocacy, they can see that the power, the rewarding nature of it is attractive, and most people, once they get going, continue with that through the rest of their career. Dr. Monty Pal: So, I'll ask you to expand on that a little bit. We have a lot of our younger ASCO members listening to this podcast, folks that are just starting out their careers in clinical practice or academia. Where does that journey begin? How do you get to the point that you're testifying in front of Congress and taking on these bigger sort of stances for the oncology community? Dr. Jason Westin: Yeah, with anything in medicine and in our careers, you have to start somewhere. And often you start with baby steps before you get in front of a panel of senators or other high-profile engagement opportunities. But often the first setting for junior colleagues to be engaged is doing things – we call them "Hill Days" – but basically being involved in kind of low-stakes meetings where you're with a group of peers, some of whom have done this multiple times before, and can get engaged talking to members of representatives' offices, and doing so in a way where it's a natural conversation that you're telling a story about a patient in your clinic, or that you're telling a personal experience from a policy that impacted your ability to deliver optimal care. It sounds stressful, but once you're doing it, it's not stressful. It's actually kind of fun. And it's a way that you can get comfort and skill with a group of peers who are there and able to help you. And ASCO has a number of ways to do that, both at the federal level, there's the Hill Day where we each April have several hundred ASCO members travel to Capitol Hill. There's also state engagement that can be done, so-called visiting at home, when representatives from the U.S. Congress or from state legislators are back in district. You can meet with your own representatives on behalf of yourself, on behalf of your organization, and advocate for policies in a way that can be beneficial to your patients. But those initial meetings that are in the office often they're low stakes because you could be meeting not with the representative but with their staff. And that staff sometimes is as young or even younger than our junior colleagues. These sometimes can be people in their 20s, but they're often extremely knowledgeable, extremely approachable, and are used to dealing with people who are new to advocacy. But they actually help make decisions within the office. So it's not a waste of time. It's actually a super useful way to engage. So, it's that first step of anything in life. The activation energy is always high to do something new. But I'd encourage people who are listening to this podcast already having some level of interest about it to explore ways that they could engage more. Dr. Monty Pal: You know, I have to tell you, I'm going to riff on what you just said for a second. ASCO couldn't make it any easier, I think, for folks to participate and get involved. So, if you're listening to this and scratching your head and thinking, "Well, where do I begin? How do I actually sign on for that meeting with a local representative?" Go to the ASCO ACT Network website. And I'll actually talk to our producer, Geraldine, to make sure we've got a link to that somewhere associated with this podcast after it's published, Jason, but I actually keep that on my browser and it's super easy. I check in there every now and then and see if there's any new policy or legislation that ASCO, you know, is sort of taking a stance on, and it gives me some fodder for conversation with my local representatives too. I mean, it's just an awesome, awesome vehicle. I'm going to segue right from there right to the issues. So, you and I are both at academic centers. You know, I think this is something that really pervades academia and enters into implications for general clinical practice. There's been this, you know, massive sort of proposal for decreased funding to the NCI and to the NIH and so forth. Tell us what ASCO is doing in that regard, and tell us perhaps how our community can help. Dr. Jason Westin: We live in interesting times, and I think that may be an understatement x 100. But obviously investments in research are things that when you're at an academic center, you see and feel that as part of your daily life. Members of Congress need to be reminded of that because there's a lot of other competing interests out there besides investing in the future through research. And being an elected representative is a hard job. That is something where you have to make difficult choices to support this, and that may mean not supporting that. And there's lots of good things where our tax dollars could be spent. And so, I'm sympathetic to the idea that there's not unlimited resources. However, ASCO has done an excellent job, and ASCO members have led the charge on this, of stating what research does, what is the benefit of research, and therefore why should this matter to elected representatives, to their staff, and to those people that they're elected to serve. And ASCO has led with a targeted campaign to basically have that message be conveyed at every opportunity to elected representatives. And each year on Hill Day, one of the asks that we have is to continue to support research: the NCI, NIH, ARPA-H, these are things that are always in the asks to make sure that there's appropriate funding. But effectively playing offense by saying, "It's not just a number on a sheet of paper, this is what it means to patients. This is what it means to potentially your loved ones in the future if you are in the opposite situation where you're not on the legislative side, but you're in the office receiving a diagnosis or receiving a difficult piece of news." We only have the tools we have now because of research, and each breakthrough has been years in the making and countless hours spent funded through the engine of innovation: clinical research and translational research. And so ASCO continues to beat that drum. You mentioned earlier the ACT Network. Just to bring that back again is a very useful, very easy tool to communicate to your elected representatives. When you sign up on the ASCO ACT website, you get emails periodically, not too much, but periodically get emails of, "This is a way you can engage with your lawmakers to speak up for this." And as you said, Monty, they make it as easy as possible. You click the button, you type in your address so that it figures out who your elected representatives are, and then it will send a letter on your behalf after like five clicks to say, "I want you to support research. I want you to vote for this particular thing which is of interest to ASCO and by definition to members of ASCO." And so the ACT Network is a way that people listening can engage without having to spend hours and significant time, but just a few clicks can send that letter to a representative in Congress. And the question could be: does that matter? Does contacting your senator or your elected representative do anything? If all they're hearing is somebody else making a different argument and they're hearing over and over again from people that want investments in AI or investments in something else besides cancer research, whatever it is, they may think that there's a ground shift that people want dollars to be spent over here as opposed to at the NIH or NCI or in federally funded research. It is important to continue to express the need for federal funding for our research. And so, it really is important for folks to engage. Dr. Monty Pal: 100%. One of the things that I think is not often obvious to a lot of our listeners is where the support for clinical trials comes from. You know, you've obviously run the whole gamut of studies as have I. You know, we have our pharmaceutical company-sponsored studies, which are in a particular bucket. But I would say that there's a very important and critical subset of studies that are actually government funded, right? NCI-funded clinical trials. If you don't mind, just explain to our audience the critical nature of the work that's being done in those types of studies and if you can, maybe compare and contrast the studies that are done in that bucket versus perhaps the pharmaceutical bucket. Dr. Jason Westin: Both are critical, and we're privileged that we have pharma studies that are sponsored and federally funded clinical research. And I think that part of a healthy ecosystem for us to develop new breakthroughs has a need for both. The pharma sponsored studies are done through the lens of trying to get an approval for an agent that's of interest so that the pharma company can then turn around and use that outside of a clinical trial after an FDA approval. And so those studies are often done through the lens of getting over the finish line by showing some superiority over an existing treatment or in a new patient population. But they're done through that lens of kind of the broadest population and sometimes relatively narrow endpoints, but to get the approval so that then the drug can be widely utilized. Clinical trials done through cooperative groups are sometimes done to try and optimize that or to try and look at comparative things that may not be as attractive to pharma studies, not necessarily going for that initial approval, but the fine tuning or the looking at health outcomes or looking at ensuring that we do studies in representative populations that may not be as well identified on the pharma sponsored trials, but basically filling out the gaps in the knowledge that we didn't gain from the initial phase 3 trial that led to the approval. And so both are critical. But if we only do pharma sponsored trials, if we don't fund federally supported research and that dries up, the fear I have, and many others have, is that we're going to be lacking a lot of knowledge about the best ways to use these great new therapies, these new immune therapies, or in my team, we do a lot of clinical trials on CAR T-cell therapies. If we don't have federally funded research to do the important clinical studies, we'll be in the dark about the best ways to use these drugs, and that's going to be a terrible shame. And so we really do need to continue to support federal research. Dr. Monty Pal: Yeah, there are no softball questions on this podcast, but I think everybody would be hard pressed to think that you and I would come on here and say, "Well, no, we don't need as much money for clinical trials and NCI funding" and so forth. But I think a really challenging issue to tackle, and this is something we thought to ask you ahead of the podcast, is what to do about the general climate of, you know, whether it's academic research or clinical practice here that seems to be getting some of our colleagues thinking about moving elsewhere. I've actually talked to a couple of folks who are picking up and moving to Europe for a variety of considerations, other continents, frankly. The U.S. has always been a leader when it comes to oncology research and, one might argue, research in general. Some have the mindset these days that we're losing that footing a little bit. What's your perspective? Are you concerned about some of the trends that you're seeing? What does your crystal ball tell you? Dr. Jason Westin: I am highly concerned about this. I think as you said, the U.S. has been a leader for a long time, but it wasn't always. This is not something that's preordained that the world-leading clinical research and translational research will always be done in the United States. That is something that has been developed as an ecosystem, as an engine for innovation and for job development, new technology development, since World War II. That's something that through intentional investments in research was developed that the best and brightest around the world, if they could choose to go anywhere, you wanted them to come to work at universities and academic places within the United States. And I think, as you said, that's at risk if you begin to dry up the investment in research or if you begin to have less focus on being engaged in research in a way that is forward thinking, not just kind of maintaining what we do now or only looking at having private, for profit sponsored research. But if you don't have the investment in the basic science research and the translational research and the forward-thinking part of it, the fear is that we lose the advantage and that other countries will say, "Thank you very much," and be happy to invest in ways to their advantage. And I think as you mentioned, there are people that are beginning to look elsewhere. I don't think that it's likely that a significant population of researchers in the U.S. who are established and have careers and families – I don't think that we're going to see a mass exodus of folks. I think the real risk to me is that the younger, up-and-coming people in undergraduate or in graduate school or in medical school and are the future superstars, that they could either choose to go into a different field, so they decide not to go into what could be the latest breakthroughs for cancer patients but could be doing something in AI or something in a different field that could be attractive to them because of less uncertainty about funding streams, or they could take that job offer if it's in a different country. And I think that's the concern is it may not be a 2026 problem, but it could be a 2036 or a 2046 problem that we reap what we sow if we don't invest in the future. Dr. Monty Pal: Indeed, indeed. You know, I've had the pleasure of reviewing abstracts for some of our big international meetings, as I'm sure you've done in the past too. I see this trend where, as before, we would see the preponderance of large phase 3 clinical trials and practice setting studies being done here in the U.S., I'm seeing this emergence of China, of other countries outside of the U.S. really taking lead on these things. And it certainly concerns me. If I had to sort of gauge this particular issue, it's at the top of my list in terms of what I'm concerned about. But I also wanted to ask you, Jason, in terms of the issues that are looming over oncology from an advocacy perspective, what else really sort of keeps you up at night? Dr. Jason Westin: I'm quite concerned about the drug shortages. I think that's something that is a surprisingly evergreen problem. This is something that is on its face illogical that we're talking about the greatest engine for research in the world being the United States and the investment that we've made in drug development and the breakthroughs that have happened for patients all around the world, many of them happen in the United States, and yet we don't necessarily have access to drugs from the 1970s or 1980s that are cheap, generic, sterile, injectable drugs. This is the cisplatins and the vincristines and the fludarabine type medications which are not the sexy ones that you see the ads in the magazine or on TV at night. These are the backbone drugs for many of our curative intent regimens for pediatrics and for heme malignancies and many solid tumors. And the fact that that's continuing to be an issue is, in my opinion, a failure to address the root causes, and those are going to require legislative solutions. The root causes here are basically a race to the bottom where the economics to invest in quality manufacturing really haven't been prioritized. And so it's a race to the cheapest price, which often means you undercut your competitor, and when you don't have the money to invest in good manufacturing processes, the factory breaks down, there's no alternative, you go into shortage. And this has been going on for a couple of decades, and I don't think there's an end in sight until we get a serious solution proposed by our elected officials. That is something that bothers me in the ways where we know what we should be doing for our patients, but if we don't have the drugs, we're left to be creative in ways we shouldn't have to do to figure out a plan B when we've got curative intent therapies. And I think that's a real shame.  There's obviously a lot of other things that are concerning related to oncology, but something that I have personally had experience with when I wanted to give a patient a CAR T-cell, and we don't have a supply of fludarabine, which is a trivial drug from decades ago in terms of the technology investments in genetically modified T-cells, to not then have access to a drug that should be pennies on the dollar and available at any time you want it is almost like the Air Force investing in building the latest stealth bomber, but then forgetting to get the jet fuel in a way that they can't use it because they don't have the tools that they need. And so I think that's something that we do need to have comprehensive solutions from our elected officials. Dr. Monty Pal: Brilliantly stated. I like that analogy a lot. Let's get into the weeds for a second. What would that proposal to Congress look like? What are we trying to put in front of them to help alleviate the drug shortages? Dr. Jason Westin: We could spend a couple hours, and I know podcasts usually are not set up to do that. And so I won't go through every part. I will direct you that there have been a couple of recent publications from ASCO specifically detailing solutions, and there was a recent white paper from the Senate Finance Committee that went through some legislative solutions being explored. So Dr. Gralow, ASCO CMO, and I recently had a publication in JCO OP detailing some solutions, more in that white paper from the Senate Finance. And then there's a working group actually going through ASCO's Health Policy Committee putting together a more detailed proposal that will be published probably around the end of 2026. Very briefly, what needs to happen is for government contracts for purchasing these drugs, there needs to be an outlay for quality, meaning that if you have a manufacturing facility that is able to deliver product on time, reliably, you get a bonus in terms of your contract. And that changes the model to prioritize the quality component of manufacturing. Without that, there's no reason to invest in maintaining your machine or upgrading the technology you have in your manufacturing plant. And so you have bottlenecks emerge because these drugs are cheap, and there's not a profit margin. So you get one factory that makes this key drug, and if that factory hasn't had an upgrade in their machines in 20 years, and that machine conks out and it takes 6 months to repair or replacement, that is an opportunity for that drug to go into shortage and causes a mad dash for big hospitals to purchase the drug that's available, leaving disparities to get amplified. It's a nightmare when those things happen, and they happen all the time. There are usually dozens, if not hundreds, of drugs in shortage at any given time. And this has been going on for decades. This is something that we do need large, system-wide fixes and that investment in quality, I think, will be a key part. Dr. Monty Pal: Yeah, brilliantly said. And I'll make sure that we actually include those articles on the tagline for this podcast as well. I'll talk to our producer about that as well.  I'm really glad you mentioned the time in your last comment there because I felt like we just started, but in fact, I think we're right at our close here, Jason, unfortunately. So, I could have gone on for a couple more hours with you. I really want to thank you for these absolutely terrific insights and thank you for all your advocacy on behalf of ASCO and oncologists at large. Dr. Jason Westin: Thank you so much for having me. I have enjoyed it. Dr. Monty Pal: Thanks a lot. And many thanks to our listeners too. You can find more information about ASCO's advocacy agenda and activities at asco.org. Finally, if you value the insights that you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Thanks so much. ASCO Advocacy Resources: Get involved in ASCO's Advocacy efforts: ASCO Advocacy Toolkit Crisis of Cancer Drug Shortages: Understanding the Causes and Proposing Sustainable Solutions, JCO Oncology Practice Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:     Dr. Monty Pal   @montypal   Dr. Jason Westin @DrJasonWestin   Follow ASCO on social media:      @ASCO on X     ASCO on Bluesky    ASCO on Facebook      ASCO on LinkedIn      Disclosures:     Dr. Monty Pal:    Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview   Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical   Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis   Dr. Jason Westin: Consulting or Advisory Role: Novartis, Kite/Gilead, Janssen Scientific Affairs, ADC Therapeutics, Bristol-Myers Squibb/Celgene/Juno, AstraZeneca, Genentech/Roche, Abbvie, MorphoSys/Incyte, Seattle Genetics, Abbvie, Chugai Pharma, Regeneron, Nurix, Genmab, Allogene Therapeutics, Lyell Immunopharma Research Funding: Janssen, Novartis, Bristol-Myers Squibb, AstraZeneca, MorphoSys/Incyte, Genentech/Roche, Allogene Therapeutics

Episodio 1236 en colaboración con MerckDentro de la campaña "Impulsando el crecimiento, inspirando confianza" de Merck en este episodio hablamos sobre el déficit de hormona de crecimiento, una enfermedad que genera un gran impacto en la vida de los niños que conviven con ella y la de sus familias.Para conocer mejor en qué consiste, el funcionamiento de la hormona del crecimiento, la importancia de su detección temprana y de su tratamiento, hablamos con la Dra. Rosenova, endocrina pediátrica del IMED Valencia.Estudio referenciado:Backeljauw P, Cappa M, Kiess W, Law L, Cookson C, Sert C, Whalen J, Dattani MT. Impact of short stature on quality of life: A systematic literature review. Growth Horm IGF Res. 2021 Apr-Jun;57-58:101392. doi: 10.1016/j.ghir.2021.101392. Epub 2021 Apr 30. PMID: 33975197.https://pubmed.ncbi.nlm.nih.gov/33975197/ Web: https://madresfera.com/Newsletter: https://www.madresfera.com/newsletter/ Música: #mobygratis https://mobygratis.com/Conviértete en un seguidor de este podcast: https://www.spreaker.com/podcast/buenos-dias-madresfera--2023835/support.

In this episode, I am pleased to welcome Chrissie Pariseau, DVM, MS, DABVP (Equine Practice), cVMA with Merck Animal Health to share some perspectives on the current EHV-1 outbreak.Join us as Dr. Pariseau unpacks the myths and facts about EHV-1 and EHM, including her professional recommendations for monitoring symptoms, testing for the virus, protecting healthy horses in your herd, and caring for those that have been exposed or infected.

Secretary Juan Pablo Segura joins BioTalk for a conversation about Virginia's growing position in the biohealth economy and the statewide strategy behind it. He outlines the significance of the new partnership with AstraZeneca, Lilly, and Merck, including up to $120 million in private investment to create a workforce development center and expand the Commonwealth's life sciences capacity. Segura talks through how Virginia approaches company recruitment, what investors are responding to, and why the state is seeing increased interest from biomanufacturing and advanced R&D companies. He also discusses Virginia's use of public-private partnerships to accelerate industry growth, strengthen the talent pipeline, and support emerging hubs across the Commonwealth. The conversation closes with a look at Virginia's role in the BioHealth Capital Region and how the regional identity helps amplify the state's message as it continues building a competitive biohealth ecosystem.   Editing and post-production work for this episode was provided by The Podcast Consultant (https://thepodcastconsultant.com). Juan Pablo Segura is the Secretary of Commerce and Trade for the Commonwealth of Virginia. He leads 13 agencies focused on economic growth, business development, and industry expansion across the state. Before entering public service, Segura spent his career building companies in the digital health sector, most notably as a founder of Babyscripts, a widely adopted maternity care platform. His work has been recognized by Startup Health, CTIA, EY, and the White House. He is a CPA and a graduate of the University of Notre Dame, and he lives in Henrico, Virginia with his family.

How This Is Building Me, hosted by world-renowned oncologist D. Ross Camidge, MD, PhD, is a podcast focused on the highs and lows, ups and downs of all those involved with cancer, cancer medicine, and cancer science across the full spectrum of life's experiences. In this episode, Dr Camidge sat down with Gideon Blumenthal, MD, vice president of Clinical Development Oncology at Merck in Silver Spring, Maryland. Drs Camidge and Blumenthal discussed Dr Blumenthal's experience serving on both sides of the oncology regulatory divide. Though initially leaning toward humanities during his education, he pursued a career in medicine. During medical school, he shifted his focus from neuroscience to oncology due to the field's high unmet need, fascinating drug development pathways, and the intensity of patient interaction. He chose to complete his hematology and oncology fellowship at the National Cancer Institute to immerse himself in translational oncology and drug development. Before joining industry, Dr Blumenthal also spent several years working for the FDA. He started there as a medical officer, focusing on all facets of drug development, from ethics and manufacturing to trial design and biostatistics. He emphasized that success at the FDA involves both approving effective agents and identifying drugs that do not work, maintaining transparency through venues like the public Oncologic Drug Advisory Committee meetings. He used FDA data to conduct independent meta-research, such as analyzing the correlation between response rates and overall survival in lung cancer. His proudest achievement at the FDA was helping to establish the Oncology Center of Excellence, which unified drug development reviews across different centers within the agency. Dr Blumenthal left the FDA in early 2020, seeking to gain direct experience in developing new therapeutics. Joining Merck, he first worked in regulatory affairs, navigating international regulations in addition to US filing procedures, which are typically prioritized in oncology. He later transitioned into clinical development, and currently focuses on new assets as Merck evolves its pipeline beyond pembrolizumab (Keytruda). Dr Blumenthal concluded that he is excited by the future of oncology, anticipating radical changes driven by new modalities and advanced biomarkers like artificial intelligence–driven digital pathology.

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of impactful events and breakthroughs that are shaping patient care and drug development.The U.S. Food and Drug Administration recently granted early approval for a combination therapy using Padcev and Keytruda for the perioperative treatment of bladder cancer, a decision made months ahead of schedule. This approval represents a significant advancement in the therapeutic landscape for this type of cancer, offering new hope to patients who have had limited treatment options. The combination of these two therapies underscores the growing trend of integrating multiple mechanisms of action to tackle complex diseases like cancer more effectively. It also highlights the potential of combination therapies to provide enhanced clinical benefits by leveraging different therapeutic targets.In another notable development, Merck's partner Kelun announced successful Phase 3 trial results for an antibody-drug conjugate combined with Keytruda in treating PD-L1-positive non-small cell lung cancer (NSCLC). The trial results demonstrated statistically significant improvements in progression-free survival compared to Keytruda alone. This finding reinforces the expanding role of antibody-drug conjugates in oncology and emphasizes the importance of biomarker-driven therapies in personalizing cancer treatment. These advancements reflect a broader industry shift towards precision medicine, which aims to improve patient outcomes by tailoring treatments based on individual patient profiles.Meanwhile, Novo Nordisk experienced setbacks as its shares fell nearly 9% following two unsuccessful Phase 3 trials of semaglutide for Alzheimer's disease. Despite these disappointing results, this outcome highlights the persistent challenges and complexities inherent in developing therapies for neurodegenerative diseases—areas where unmet needs remain substantial. The market's reaction reflects investor sensitivity to clinical trial outcomes, particularly in high-stakes areas like Alzheimer's where breakthroughs are eagerly anticipated.Switching gears to AstraZeneca, the company is making a strategic move by expanding its manufacturing capabilities with a $2 billion investment in Maryland. This expansion reflects an ongoing trend among pharmaceutical companies to enhance their production infrastructure, driven by increasing demand for biologics and complex therapeutics. Such investments are crucial for supporting large-scale production needs and ensuring robust supply chains that are essential for meeting global health demands.In regulatory news, a collective letter from biotech CEOs addressed to FDA director Marty Makary has raised concerns about regulatory stability in the U.S., with 82% of biopharma respondents expressing apprehension over the FDA's ability to function predictably. This plea underscores how regulatory volatility can hinder innovation and emphasizes the importance of consistent policies that support long-term research and development efforts.In clinical trial updates, Bayer's oral FXIa inhibitor asundexian has shown promise in reducing stroke risk during Phase 3 trials. These findings revive interest in FXIa inhibitors as potentially blockbuster drugs after previous setbacks in this class. This development illustrates ongoing efforts to identify novel anticoagulant therapies that balance efficacy and safety, offering new hope for improved therapeutic options.Now turning our attention to Johnson & Johnson's recent setback with their anti-tau antibody posdinemab in a phase 2 trial targeting Alzheimer's disease. The trial was unable to demonstrate a significant slowing of clinical decline, leading JSupport the show

Marian Wentworth, President & CEO, Management Sciences for Health (MSH), at age 13 started working in a local factory. Attended the famous Latin School in Chicago. Studied math at Harvard. Then joined Merck as it was "growing ferociously fast." Stayed 27 years, grew and led the vaccine business to $6 billion. Was the "quant jock." Spearheaded the launch of Gardasil, the HPV vaccine. Then pivoted to MSH. It was important "not having a pharmaceutical company on my business card." Now as she reflects on the stunning year of 2025, a series of radical pivots for MSH, is there space for MSH in the America First Global Health Strategy? Yes. Excited by the Accra Reset? Yes. Where does this leave MSH? "I believe this time is a crucible."

Dr. Linda Duska and Dr. Kathleen Moore discuss key studies in the evolving controversy over radical upfront surgery versus neoadjuvant chemotherapy in advanced ovarian cancer. TRANSCRIPT Dr. Linda Duska: Hello, and welcome to the ASCO Daily News Podcast. I am your guest host, Dr. Linda Duska. I am a professor of obstetrics and gynecology at the University of Virginia School of Medicine.  On today's episode, we will explore the management of advanced ovarian cancer, specifically with respect to a question that has really stirred some controversy over time, going all the way back more than 20 years: Should we be doing radical upfront surgery in advanced ovarian cancer, or should we be doing neoadjuvant chemotherapy? So, there was a lot of hype about the TRUST study, also called ENGOT ov33/AGO-OVAR OP7, a Phase 3 randomized study that compares upfront surgery with neoadjuvant chemotherapy followed by interval surgery. So, I want to talk about that study today. And joining me for the discussion is Dr. Kathleen Moore, a professor also of obstetrics and gynecology at the University of Oklahoma and the deputy director of the Stephenson Cancer Center, also at the University of Oklahoma Health Sciences.  Dr. Moore, it is so great to be speaking with you today. Thanks for doing this. Dr. Kathleen Moore: Yeah, it's fun to be here. This is going to be fun. Dr. Linda Duska: FYI for our listeners, both of our full disclosures are available in the transcript of this episode.  So let's just jump right in. We already alluded to the fact that the TRUST study addresses a question we have been grappling with in our field. Here's the thing, we have four prior randomized trials on this exact same topic. So, share with me why we needed another one and what maybe was different about this one? Dr. Kathleen Moore: That is, I think, the key question. So we have to level-set kind of our history. Let's start with, why is this even a question? Like, why are we even talking about this today? When we are taking care of a patient with newly diagnosed ovarian cancer, the aim of surgery in advanced ovarian cancer ideally is to prolong a patient's likelihood of disease-free survival, or if you want to use the term "remission," you can use the term "remission." And I think we can all agree that our objective is to improve overall survival in a way that also does not compromise her quality of life through surgical complications, which can have a big effect. The standard for many decades, certainly my entire career, which is now over 20 years, has been to pursue what we call primary cytoreductive surgery, meaning you get a diagnosis and we go right to the operating room with a goal of achieving what we call "no gross residual." That is very different – in the olden days, you would say "optimal" and get down to some predefined small amount of tumor. Now, the goal is you remove everything you can see.  The alternative strategy to that is neoadjuvant chemotherapy followed by interval cytoreductive surgery, and that has been the, quote-unquote, "safer" route because you chemically cytoreduce the cancer, and so, the resulting surgery, I will tell you, is not necessarily easy at all. It can still be very radical surgeries, but they tend to be less radical, less need for bowel resections, splenectomy, radical procedures, and in a short-term look, would be considered safer from a postoperative consideration. Dr. Linda Duska: Well, and also maybe more likely to be successful, right? Because there's less disease, maybe, theoretically. Dr. Kathleen Moore: More likely to be successful in getting to no gross residual. Dr. Linda Duska: Right. Yeah, exactly. Dr. Kathleen Moore: I agree with that. And so, so if the end game, regardless of timing, is you get to no gross residual and you help a patient and there's no difference in overall survival, then it's a no-brainer. We would not be having this conversation. But there remains a question around, while it may be more likely to get to no gross residual, it may be, and I think we can all agree, a less radical, safer surgery, do you lose survival in the long term by this approach? This has become an increasing concern because of the increase in rates of use of neoadjuvant, not only in this country, but abroad. And so, you mentioned the four prior studies. We will not be able to go through them completely. Dr. Linda Duska: Let's talk about the two modern ones, the two from 2020 because neither one of them showed a difference in overall survival, which I think we can agree is, at the end of the day, yes, PFS would be great, but OS is what we're looking for. Dr. Kathleen Moore: OS is definitely what we're looking for. I do think a marked improvement in PFS, like a real prolongation in disease-free survival, for me would be also enough. A modest improvement does not really cut it, but if you are really, really prolonging PFS, you should see that-  Dr. Linda Duska: -manifest in OS. Dr. Kathleen Moore: Yeah, yeah. Okay. So let's talk about the two modern ones. The older ones are EORTC and CHORUS, which I think we've talked about. The two more modern ones are SCORPION and JCOG0602. So, SCORPION was interesting. SCORPION was a very small study, though. So one could say it's underpowered. 170 patients. And they looked at only patients that were incredibly high risk. So, they had to have a Fagotti score, I believe, of over 9, but they were not looking at just low volume disease. Like, those patients were not enrolled in SCORPION. It was patients where you really were questioning, "Should I go to the OR or should I do neoadjuvant? Like, what's the better thing?" It is easy when it's low volume. You're like, "We're going." These were the patients who were like, "Hm, you know, what should I do?" High volume. Patients were young, about 55. The criticism of the older studies, there are many criticisms, but one of them is that, the criticism that is lobbied is that they did not really try. Whatever surgery you got, they did not really try with median operative times of 180 minutes for primary cytoreduction, 120 for neoadjuvant. Like, you and I both know, if you're in a big primary debulking, you're there all day. It's 6 hours. Dr. Linda Duska: Right, and there was no quality control for those studies, either. Dr. Kathleen Moore: No quality control. So, SCORPION, they went 451-minute median for surgery. Like, they really went for it versus four hours and then 253 for the interval, 4 hours. They really went for it on both arms. Complete gross resection was achieved in 50% of the primary cytoreduced. So even though they went for it with these very long surgeries, they only got to the goal half the time. It was almost 80% in the interval group. So they were more successful there. And there was absolutely no difference in PFS or OS. They were right about 15 months PFS, right about 40 months OS.  JCOG0602, of course, done in Japan, a big study, 300 patients, a little bit older population. Surprisingly more stage IV disease in this study than were in SCORPION. SCORPION did not have a lot of stage IV, despite being very bulky tumors. So a third of patients were stage IV. They also had relatively shorter operative times, I would say, 240 minutes for primary, 302 for interval. So still kind of short. Complete gross resection was not achieved very often. 30% of primary cytoreduction. That is not acceptable. Dr. Linda Duska: Well, so let's talk about TRUST. What was different about TRUST? Why was this an important study for us to see? Dr. Kathleen Moore: So the criticism of all of these, and I am not trying to throw shade at anyone, but the criticism of all of these is if you are putting surgery to the test, you are putting the surgeon to the test. And you are assuming that all surgeons are trained equally and are willing to do what it takes to get someone to no gross residual. Dr. Linda Duska: And are in a center that can support the post-op care for those patients. Dr. Kathleen Moore: Which can be ICU care, prolonged time. Absolutely. So when you just open these broadly, you're assuming everyone has the surgical skills and is comfortable doing that and has backup. Everybody has an ICU. Everyone has a blood bank, and you are willing to do that. And that assumption could be wrong. And so what TRUST said is, "Okay, we are only going to open this at centers that have shown they can achieve a certain level of primary cytoreduction to no gross residual disease." And so there was quality criteria. It was based on – it was mostly a European study – so ESGO criteria were used to only allow certified centers to participate. They had to have a surgical volume of over 36 cytoreductive surgeries per year. So you could not be a low volume surgeon. Your complete resection rates that were reported had to be greater than 50% in the upfront setting. I told you on the JCOG, it was 30%. Dr. Linda Duska: Right. So these were the best of the best. This was the best possible surgical situation you could put these patients in, right? Dr. Kathleen Moore: Absolutely. And you support all the things so you could mitigate postoperative complications as well. Dr. Linda Duska: So we are asking the question now again in the ideal situation, right? Dr. Kathleen Moore: Right. Dr. Linda Duska: Which, we can talk about, may or may not be generalizable to real life, but that's a separate issue because we certainly don't have those conditions everywhere where people get cared for with ovarian cancer. But how would you interpret the results of this study? Did it show us anything different? Dr. Kathleen Moore: I am going to say how we should interpret it and then what I am thinking about. It is a negative study. It was designed to show improvement in overall survival in these ideal settings in patients with FIGO stage IIIB and C, they excluded A, these low volume tumors that should absolutely be getting surgery. So FIGO stage IIIB and C and IVA and B that were fit enough to undergo radical surgery randomized to primary cytoreduction or neoadjuvant with interval, and were all given the correct chemo. Dr. Linda Duska: And they were allowed bevacizumab and PARP, also. They could have bevacizumab and PARP. Dr. Kathleen Moore: They were allowed bevacizumab and PARP. Not many of them got PARP, but it was distributed equally, so that would not be a confounder. And so that was important. Overall survival is the endpoint. It was a big study. You know, it was almost 600 patients. So appropriately powered. So let's look at what they reported. When they looked at the patients who were enrolled, this is a large study, almost 600 patients, 345 in the primary cytoreductive arm and 343 in the neoadjuvant arm. Complete resection in these patients was 70% in the primary cytoreductive arm and 85% in the neoadjuvant arm. So in both arms, it was very high. So your selection of site and surgeon worked. You got people to their optimal outcome. So that is very different than any other study that has been reported to date. But what we saw when we looked at overall survival was no statistical difference. The median was, and I know we do not like to talk about medians, but the median in the primary cytoreductive arm was 54 months versus 48 months in the neoadjuvant arm with a hazard ratio of 0.89 and, of course, the confidence interval crossed one. So this is not statistically significant. And that was the primary endpoint. Dr. Linda Duska: I know you are getting to this. They did look at PFS, and that was statistically significant, but to your point about what are we looking for for a reasonable PFS difference? It was about two months difference. When I think about this study, and I know you are coming to this, what I thought was most interesting about this trial, besides the fact that the OS, the primary endpoint was negative, was the subgroup analyses that they did. And, of course, these are hypothesis-generating only. But if you look at, for example, specifically only the stage III group, that group did seem to potentially, again, hypothesis generating, but they did seem to benefit from upfront surgery.  And then one other thing that I want to touch on before we run out of time is, do we think it matters if the patient is BRCA germline positive? Do we think it matters if there is something in particular about that patient from a biomarker standpoint that is different? I am hopeful that more data will be coming out of this study that will help inform this. Of course, unpowered, hypothesis-generating only, but it's just really interesting. What do you think of their subset analysis? Dr. Kathleen Moore: Yeah, I think the subsets are what we are going to be talking about, but we have to emphasize that this was a negative trial as designed. Dr. Linda Duska: Absolutely. Yes. Dr. Kathleen Moore: So we cannot be apologists and be like, "But this or that." It was a negative trial as designed. Now, I am a human and a clinician, and I want what is best for my patients. So I am going to, like, go down the path of subset analyses. So if you look at the stage III tumors that got complete cytoreduction, which was 70% of the cases, your PFS was almost 28 months versus 21.8 months. Dr. Linda Duska: Yes, it becomes more significant. Dr. Kathleen Moore: Yeah, that hazard ratio is 0.69. Again, it is a subset. So even though the P value here is statistically significant, it actually should not have a P value because it is an exploratory analysis. So we have to be very careful. But the hazard ratio is 0.69. So the hypothesis is in this setting, if you're stage III and you go for it and you get someone to no gross residual versus an interval cytoreduction, you could potentially have a 31% reduction in the rate of progression for that patient who got primary cytoreduction. And you see a similar trend in the stage III patients, if you look at overall survival, although the post-progression survival is so long, it's a little bit narrow of a margin.  But I do think there are some nuggets here that, one of our colleagues who is really one of the experts in surgical studies, Dr. Mario Leitao, posted this on X, and I think it really resonated after this because we were all saying, "But what about the subsets?" He is like, "It's a negative study." But at the end of the day, you are going to sit with your patient. The patient should be seen by a GYN oncologist or surgical oncologist with specialty in cytoreduction and a medical oncologist, you know, if that person does not give chemo, and the decision should be made about what to do for that individual patient in that setting. Dr. Linda Duska: Agreed. And along those lines, if you look carefully at their data, the patients who had an upfront cytoreduction had almost twice the risk of having a stoma than the patients who had an interval cytoreduction. And they also had a higher risk of needing to have a bowel resection. The numbers were small, but still, when you look at the surgical complications, as you've already said, they're higher in the upfront group than they are in the interval group. That needs to be taken into account as well when counseling a patient, right? When you have a patient in front of you who says to you, "Dr. Moore, you can take out whatever you want, but whatever you do, don't make me a bag." As long as the patient understands what that means and what they're asking us to do, I think that we need to think about that. Dr. Kathleen Moore: I think that is a great point. And I have definitely seen in our practice, patients who say, "I absolutely would not want an ostomy. It's a nonstarter for me." And we do make different decisions. And you have to just say, "That's the decision we've made," and you kind of move on, and you can't look back and say, "Well, I wish I would have, could have, should have done something else." That is what the patient wants. Ultimately, that patient, her family, autonomous beings, they need to be fully counseled, and you need to counsel that patient as to the site that you are in, her volume of disease, and what you think you can achieve. In my opinion, a patient with stage III cancer who you have the site and the capabilities to get to no gross residual should go to the OR first. That is what I believe. I do not anymore think that for stage IV. I think that this is pretty convincing to me that that is probably a harmful thing. However, I want you to react to this. I think I am going to be a little unpopular in saying this, but for me, one of the biggest take-homes from TRUST was that whether or not, and we can talk about the subsets and the stage III looked better, and I think it did, but both groups did really well. Like, really well. And these were patients with large volume disease. This was not cherry-picked small volume stage IIIs that you could have done an optimal just by doing a hysterectomy. You know, these were patients that needed radical surgery. And both did well. And so what it speaks to me is that anytime you are going to operate on someone with ovary, whether it be frontline, whether it be a primary or interval, you need a high-volume surgeon. That is what I think this means to me. Like, I would want high volume surgeon at a center that could do these surgeries, getting that patient, my family member, me, to no gross residual. That is important. And you and I are both in training centers. I think we ought to take a really strong look at, are we preparing people to do the surgeries that are necessary to get someone to no gross residual 70% and 85% of the time? Dr. Linda Duska: We are going to run out of time, but I want to address that and ask you a provocative question. So, I completely agree with what you said, that surgery is important. But I also think one of the reasons these patients in this study did so well is because all of the incredible new therapies that we have for patients. Because OS is not just about surgery. It is about surgery, but it is also about all of the amazing new therapies we have that you and others have helped us to get through clinical research. And so, how much of that do you think, like, for example, if you look at the PFS and OS rates from CHORUS and EORTC, I get it that they're, that they're not the same. It's different patients, different populations, can't do cross-trial comparisons. But the OS, as you said, in this study was 54 months and 48 months, which is, compared to 2010, we're doing much, much better. It is not just the surgery, it is also all the amazing treatment options we have for these patients, including PARP, including MIRV, including lots of other new therapies. How do you fit that into thinking about all of this? Dr. Kathleen Moore: I do think we are seeing, and we know this just from epidemiologic data that the prevalence of ovarian cancer in many of the countries where the study was done is increasing, despite a decrease in incidence. And why is that? Because people are living longer. Dr. Linda Duska: People are living longer, yeah. Dr. Kathleen Moore: Which is phenomenal. That is what we want. And we do have, I think, better supportive care now. PARP inhibitors in the frontline, which not many of these patients had. Now some of them, this is mainly in Europe, will have gotten them in the first maintenance setting, and I do think that impacts outcome. We do not have that data yet, you know, to kind of see what, I would be really interested to see. We do not do this well because in ovarian cancer, post-progression survival can be so long, we do not do well of tracking what people get when they come off a clinical trial to see how that could impact – you know, how many of them got another surgery? How many of them got a PARP? I think this group probably missed the ADC wave for the most part, because this, mirvetuximab is just very recently available in Europe. Dr. Linda Duska: Unless they were on trial. Dr. Kathleen Moore: Unless they were on trial. But I mean, I think we will have to see. 600 patients, I would bet a lot of them missed the ADC wave. So, I do not know that we can say we know what drove these phenomenal – these are some of the best curves we've seen outside of BRCA. And then coming back to your point about the BRCA population here, that is a really critical question that I do not know that we're ever going to answer. There have been hypotheses around a tumor that is driven by BRCA, if you surgically cytoreduced it, and then chemically cytoreduced it with chemo, and so you're starting PARP with nothing visible and likely still homogeneous clones. Is that the group we cured? And then if you give chemo first before surgery, it allows more rapid development of heterogeneity and more clonal evolution that those are patients who are less likely to be cured, even if they do get cytoreduced to nothing at interval with use of PARP inhibitor in the front line. That is a question that many have brought up as something we would like to understand better. Like, if you are BRCA, should you always just go for it or not? I do not know that we're ever going to really get to that. We are trying to look at some of the other studies and just see if you got neoadjuvant and you had BRCA, was anyone cured? I think that is a question on SOLO1 I would like to know the answer to, and I don't yet, that may help us get to that. But that's sort of something we do think about. You should have a fair number of them in TRUST. It wasn't a stratification factor, as I remember. Dr. Linda Duska: No, it wasn't. They stratified by center, age, and ECOG status Dr. Kathleen Moore: So you would hope with randomization that you would have an equal number in each arm. And they may be able to pull that out and do a very exploratory look. But I would be interested to see just completely hypothesis-generating what this looks like for the patients with BRCA, and I hope that they will present that. I know they're busy at work. They have translational work. They have a lot pending with TRUST. It's an incredibly rich resource that I think is going to teach us a lot, and I am excited to see what they do next. Dr. Linda Duska: So, outside of TRUST, we are out of time. I just want to give you a moment if there were any other messages that you want to share with our listeners before we wrap up. Dr. Kathleen Moore: It's an exciting time to be in GYN oncology. For so long, it was just chemo, and then the PARP inhibitors nudged us along quite a bit. We did move more patients, I believe, to the cure fraction. When we ultimately see OS, I think we'll be able to say that definitively, and that is exciting. But, you know, that is the minority of our patients. And while HRD positive benefits tremendously from PARP, I am not as sure we've moved as many to the cure fraction. Time will tell. But 50% of our patients have these tumors that are less HRD. They have a worse prognosis. I think we can say that and recur more quickly. And so the advent of these antibody-drug conjugates, and we could name 20 of them in development in GYN right now, targeting tumor-associated antigens because we're not really driven by mutations other than BRCA. We do not have a lot of things to come after. We're not lung cancer. We are not breast cancer. But we do have a lot of proteins on the surface of our cancers, and we are finally able to leverage that with some very active regimens. And we're in the early phases, I would say, of really understanding how best to use those, how best to position them, and which one to select for whom in a setting where there is going to be obvious overlap of the targets. So we're going to be really working this problem. It is a good problem. A lot of drugs that work pretty well. How do you individualize for a patient, the patient in front of you with three different markers? How do you optimize it? Where do you put them to really prolong survival? And then we finally have cell surface. We saw at ASCO, CDK2 come into play here for the first time, we've got a cell cycle inhibitor. We've been working on WEE1 and ATR for a long time. CDK2s may hit. Response rates were respectable in a resistant population that was cyclin E overexpressing. We've been working on that biomarker for a long time with a toxicity profile that was surprisingly clean, which I like to see for our patients. So that is a different platform. I think we have got bispecifics on the rise. So there is a pipeline of things behind the ADCs, which is important because we need more than one thing, that makes me feel like in the future, I am probably not going to be using doxil ever for platinum-resistant disease. So, I am going to be excited to retire some of those things. We will say, "Remember when we used to use doxil for platinum-resistant disease?" Dr. Linda Duska: I will be retired by then, but thanks for that thought. Dr. Kathleen Moore: I will remind you. Dr. Linda Duska: You are right. It is such an incredibly exciting time to be taking care of ovarian cancer patients with all the opportunities.  And I want to thank you for sharing your valuable insights with us on this podcast today and for your great work to advance care for patients with GYN cancers. Dr. Kathleen Moore: Likewise. Thanks for having me. Dr. Linda Duska: And thank you to our listeners for your time today. You will find links to the TRUST study and other studies discussed today in the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers:   Dr. Linda Duska  @Lduska Dr. Kathleen Moore Follow ASCO on social media:     @ASCO on X (formerly Twitter) ASCO on Bluesky   ASCO on Facebook     ASCO on LinkedIn     Disclosures of Potential Conflicts of Interest:    Dr. Linda Duska:   Consulting or Advisory Role: Regeneron, Inovio Pharmaceuticals, Merck, Ellipses Pharma  Research Funding (Inst.): GlaxoSmithKline, Millenium, Bristol-Myers Squibb, Aeterna Zentaris, Novartis, Abbvie, Tesaro, Cerulean Pharma, Aduro Biotech, Advaxis, Ludwig Institute for Cancer Research, Leap Therapeutics  Patents, Royalties, Other Intellectual Property: UptToDate, Editor, British Journal of Ob/Gyn  Dr. Kathleen Moore: Leadership: GOG Partners, NRG Ovarian Committee Chair Honoraria: Astellas Medivation, Clearity Foundation, IDEOlogy Health, Medscape, Great Debates and Updates, OncLive/MJH Life Sciences, MD Outlook, Curio Science, Plexus, University of Florida, University of Arkansas for Medical Sciences, Congress Chanel, BIOPHARM, CEA/CCO, Physician Education Resource (PER), Research to Practice, Med Learning Group, Peerview, Peerview, PeerVoice, CME Outfitters, Virtual Incision Consulting/Advisory Role: Genentech/Roche, Immunogen, AstraZeneca, Merck, Eisai, Verastem/Pharmacyclics, AADi, Caris Life Sciences, Iovance Biotherapeutics, Janssen Oncology, Regeneron, zentalis, Daiichi Sankyo Europe GmbH, BioNTech SE, Immunocore, Seagen, Takeda Science Foundation, Zymeworks, Profound Bio, ADC Therapeutics, Third Arc, Loxo/Lilly, Bristol Myers Squibb Foundation, Tango Therapeutics, Abbvie, T Knife, F Hoffman La Roche, Tubulis GmbH, Clovis Oncology, Kivu, Genmab/Seagen, Kivu, Genmab/Seagen, Whitehawk, OnCusp Therapeutics, Natera, BeiGene, Karyopharm Therapeutics, Day One Biopharmaceuticals, Debiopharm Group, Foundation Medicine, Novocure Research Funding (Inst.): Mersana, GSK/Tesaro, Duality Biologics, Mersana, GSK/Tesaro, Duality Biologics, Merck, Regeneron, Verasatem, AstraZeneca, Immunogen, Daiichi Sankyo/Lilly, Immunocore, Torl Biotherapeutics, Allarity Therapeutics, IDEAYA Biosciences, Zymeworks, Schrodinger Other Relationship (Inst.): GOG Partners

Have you ever noticed how much stronger teams become when people feel encouraged, valued, and supported?In this episode of The Executive Appeal, Alex D. Tremble, CEO of GPS Leadership Solutions, sits down with Celeste Warren, former VP and Chief Diversity & Inclusion Officer at Merck and founder of Celeste Warren Consulting LLC, to explore how authentic leadership, encouragement, and inclusive practices shape team success and workplace culture.

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Plus: Cidara Therapeutics stock doubles after a bid from Merck. And Under Armour shares fall after dropping a deal with Stephen Curry. Katherine Sullivan hosts. Sign up for the WSJ's free What's News newsletter. An artificial-intelligence tool assisted in the making of this episode by creating summaries that were based on Wall Street Journal reporting and reviewed and adapted by an editor.  Learn more about your ad choices. Visit megaphone.fm/adchoices

What's on your mind? Let CX Passport know...Pharma and CX… not exactly two words you hear together often. But what happens when customer experience thinking meets healthcare? Silvi Haldipur has lived it. From personal experience to transforming patient, provider, and payer experiences at GSK and Merck, she's proving that empathy and data can coexist to truly save lives.5 Insights from This Episode • CX in pharma isn't impossible… it's essential. Silvi shares how she turned a deeply personal healthcare experience into her mission for better patient outcomes. • Beyond ads and emails… why support, not slogans, is what patients really need. • What pharma can learn from design thinking, ethnography, and on-the-ground empathy. • How “wraparound programs” simplify post-prescription chaos and actually improve outcomes. • The rise of the Chief Customer Experience Officer in pharma… and why it's long overdue.

What does it take to turn chaotic, costly B2B events into powerful engines of ROI and connection? In this episode of Predictable B2B Success, host Vinay Koshy sits down with Hailey Ingraham, Marketing Director at Event Cadence, a fast-growing event management platform trusted by organizations from MIT to Merck. Hailey Ingraham shares her journey from content marketing newbie to director, revealing the storytelling secrets that not only build communities but drive tangible, measurable business outcomes from in-person, virtual, and hybrid events. Discover the unexpected strengths that niche specialization can unlock, why evolving your event strategy is more than just survival, and how technology, when applied thoughtfully, can enhance connection rather than replace it. Hailey Ingraham gets candid about overcoming industry challenges, such as the notorious struggle to prove ROI, and shares practical tips for making your next event more data-driven, engaging, and memorable. Plus, hear about the creative giveaways that attract attention at crowded trade shows and why storytelling remains the ultimate marketing superpower. Whether you're an event manager, marketer, or B2B leader, this episode will spark fresh ideas about the future of events and the art of driving real results. Some topics we explore in this episode include: Storytelling in B2B Marketing – How narrative drives engagement and sales.Adapting in Event Management – Pivoting business strategies amid industry shifts, especially during COVID-19.Measuring Event ROI – Solutions and challenges for proving event value.Technology's Role in Events – Enhancing attendee experience with features and real-time updates.Focusing on Niche Audiences – The impact of starting with life sciences/pharma and expanding.Customer Success & Word-of-Mouth – Building growth through support and satisfied clients.Event Data & Business Intelligence – Using analytics and AI for decision-making and optimization.Content Creation & Customer Stories – Creating relatable, engaging material based on customer feedback.Balancing Automation & Human Touch – Ensuring tech enhances, not replaces, human interaction.Growth Strategies – Trade shows, partnerships, and thought leadership as drivers for business expansion.And much, much more...

Sen. Jeanne Shaheen of New Hampshire, one of the Democrats who joined Republicans to advance a funding measure to potentially end the government shutdown, joins "CBS Mornings" to discuss the vote that has divided her party. Shaheen placed blame on President Trump and Republicans regarding health care costs, which has been at the center of the shutdown and said "we're going to live to fight another day" as the new agreement would guarantee a vote on extending Affordable Care Act subsidies. The drug maker Merck says it's developed a new daily cholesterol pill that can dramatically lower LDL, or bad cholesterol. CBS News medical contributor Dr. Celine Gounder explains what to know. The Centers for Disease Control and Prevention is investigating more than a dozen cases of infant botulism tied to the formula brand ByHeart, prompting a voluntary recall of the product. Officials say there have been 13 cases across 10 states since August. No deaths have been reported. FDA commissioner Dr. Marty Makary joins "CBS Mornings" to discuss the agency's announcement Thursday that boxed warnings will be removed from many estrogen products used for hormone therapy, a treatment that helps alleviate the symptoms of menopause. CBS News contributor David Begnaud went to San Diego in Southern California to meet a remarkable veteran who just turned 100. The Home Depot Foundation, and a group of employee volunteers stepped up to honor his legacy with an incredible surprise — a complete landscape makeover. (Sponsored by The Home Depot Foundation) Actor Josh Brolin and director Edgar Wright talk about the highly anticipated movie, "The Running Man," based on Stephen King's novel. Brolin talks about his role. The two also discuss working with Glen Powell and King. To learn more about listener data and our privacy practices visit: https://www.audacyinc.com/privacy-policy Learn more about your ad choices. Visit https://podcastchoices.com/adchoices

Learn how to restore your adrenal function and reclaim your energy with this comprehensive 90-day reset plan. Nurse Doza maps out a practical approach to reversing adrenal fatigue through measurable testing (DHEAS and HRV), lifestyle modifications including belly breathing and sunlight exposure, and targeted supplementation to support your body's stress response and energy production. Character count: 394 5 KEY TAKEAWAYS Measure Your Adrenal Function: DHEAS blood testing (optimal range: 200-250) provides a stable measurement of adrenal function over time without daily variation, while Heart Rate Variability (HRV) tracks your recent stress response and nervous system health in real-time. Activate Rest and Digest Mode: Belly breathing (diaphragmatic breathing) actively shifts your nervous system from fight-or-flight to rest-and-digest mode by increasing parasympathetic activity, lowering cortisol levels, and improving HRV with just 4-7 minutes daily. Morning Sunlight Resets Your System: Getting sunlight within the first hour of waking naturally boosts cortisol production, increases serotonin synthesis, provides vitamin D, and sets your circadian rhythm for better sleep—aim for 30-45 minutes of direct sunlight without sunglasses. Support with Targeted Nutrition: Bovine adrenal gland extracts provide building blocks for your own adrenal glands to resume normal function, a practice used successfully since the early 1900s, while B vitamins (especially B5 and B6) help regulate cortisol production and support energy metabolism. Address Underlying Trauma: Unresolved trauma from childhood or adulthood chronically activates your stress response and suppresses adrenal function—addressing it through therapies like CBT, EMDR, or somatic experiencing is essential for long-term adrenal recovery and nervous system regulation. FEATURED PRODUCT Zen – featuring bovine adrenal gland extracts, is designed to support adrenal function and help regulate cortisol production—key factors in restoring energy and recovering from burnout as discussed in this episode. The bovine adrenal gland provides the building blocks for your own adrenal glands to resume normal function, while B vitamins (especially B5 and B6) support healthy stress response. Zen is the gentle, targeted support your adrenals need during this 90-day reset. Shop Zen TIMESTAMPS 00:00 – START – Welcome and episode overview 02:15 – Understanding adrenal glands beyond traditional teaching 05:30 – Common symptoms of adrenal dysfunction and chronic fatigue 08:45 – First 30 days: Measuring DHEAS blood test for adrenal function 12:20 – Understanding Heart Rate Variability (HRV) for stress monitoring 16:40 – Optimal ranges for DHEAS and HRV measurements 20:15 – Days 31-60: Switching from fight-or-flight to rest-and-digest 23:50 – Belly breathing (diaphragmatic breathing) technique explained 27:30 – Legs on the wall yoga pose for nervous system reset 31:10 – Morning sunlight exposure and circadian rhythm 35:20 – Days 61-90: Zen supplement with bovine adrenal gland and B vitamins 40:45 – Making sleep a priority throughout the reset 44:20 – Addressing trauma for long-term adrenal recovery 47:00 – 90-day plan recap and final recommendations RESOURCES Mayo Clinic: Adrenal Fatigue – Overview of adrenal fatigue as a general term for symptoms like tiredness, weakness, and sleep problems https://www.mayoclinic.org/diseases-conditions/addisons-disease/expert-answers/adrenal-fatigue/faq-20057906 DHEA Potent Effects on Cytokine Production – Research on DHEA's anti-inflammatory effects and IL-2 synthesis https://www.sciencedirect.com/science/article/abs/pii/S0083672918300347?via%3Dihub DHEA-S vs DHEA: Brain Health – Explains why DHEA-S doesn't exhibit diurnal rhythm and is more stable for testing https://www.zrtlab.com/blog/archive/difference-dhea-dheas-brain-health Neuroendocrine and Immune System Communication – Study on DHEA, inflammation, infection, and the HPA axis https://pmc.ncbi.nlm.nih.gov/articles/PMC9207529/ Heart Rate Variability and Mortality – Research showing low HRV predicts mortality, morbidity, depression, anxiety, and chronic stress https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5575449/ Fight-or-Flight Response Overview – Comprehensive guide to autonomic nervous system stress response https://positivepsychology.com/fight-or-flight-response/ Diaphragmatic Breathing Benefits – Study showing DB reduces respiratory rate and salivary cortisol levels https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7602530/ VA: Diaphragmatic Breathing and HRV – Veterans Affairs resource on how diaphragmatic breathing increases heart rate variability https://www.va.gov/WHOLEHEALTHLIBRARY/tools/diaphragmatic-breathing.asp Health Effects of the Sun and Vitamin D – Article on morning light exposure and circadian rhythm https://www.businessinsider.com/health-effects-of-the-sun-and-vitamin-d-2014-6 Morning Sunlight Exposure Benefits – Guidelines for optimal morning light exposure (30-45 minutes within first hour) https://www.verywellhealth.com/morning-sunlight-exposure-3973908 Music with Binaural Beat Therapy – Study on sympathetic/parasympathetic responses https://pubmed.ncbi.nlm.nih.gov/28544507/ Whole Body Vibration and HRV – Research on WBV improving heart rate variability https://pubmed.ncbi.nlm.nih.gov/30100286/ Glandular Therapies for Modern Challenges – Overview of how adrenal glandulars provide building blocks for adrenal function https://www.clinicaleducation.org/news/glandular-therapies-an-age-old-solution-for-modern-challenges-and-chronic-disease/ Historical Use of Adrenal Glandulars – Dr. Isaacs research on Merck's 1905 Manual and bovine adrenal content https://pmc.ncbi.nlm.nih.gov/articles/PMC10289114/ Heart Rate Variability and Nighttime – Study showing HRV is typically higher during nighttime https://www.ahajournals.org/doi/full/10.1161/01.cir.91.7.1918 Early Evening Light and Sleep – Research on how light timing affects sleep quality https://www.nature.com/articles/s41598-019-52352-w Melatonin and Happiness Levels – Study on relationship between melatonin, cortisol, and mood https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4449495/ Melatonin and Adrenal Glands – Research on melatonin's role as endogenous pacemaker for adrenal function https://www.ncbi.nlm.nih.gov/sites/books/NBK550972/ MSW Nutrition Zen Supplement – Bovine adrenal gland with B5 and B6 for adrenal support https://www.mswnutrition.com/products/zen Nursedoza.com – Book a consultation for adrenal testing and personalized protocols http://www.nursedoza.com/ CONNECT

Bonus Episode for Nov. 4. The weight-loss-drug arms race is only heating up, as Novo Nordisk attempts to snatch drugmaker Metsera away from Pfizer. But can either company compete with Zepbound seller Eli Lilly? WSJ reporter Peter Loftus discusses what earnings from Big Pharma, including AbbVie, Bristol Myers Squibb and Merck, say about the future of the industry and how companies are responding to President Trump's drug-pricing plans, including TrumpRx. WSJ Heard on the Street columnist David Wainer hosts this special bonus episode of What's News in Earnings, where we dig into companies' earnings reports and analyst calls to find out what's going on under the hood of the American economy. Sign up for the WSJ's free Markets A.M. newsletter. Further Reading: Novo Nordisk Sweetens Offer for Metsera - WSJ Pfizer Sues Seeking to Block Novo Nordisk's Effort to Undo Weight-Loss Drug Deal Why Pfizer Can Still Prevail in the Obesity Fight With Novo Nordisk The Day Pharma's Weight-Loss Gold Rush Intensified Pfizer Profit Falls Amid Lower Covid-19 Drug Demand Novo Nordisk Seeks to Outmuscle Pfizer With $9 Billion Bid for Metsera Novo Nordisk to Shake Up Board After Obesity-Market Challenges Mounjaro Powers Eli Lilly to Bumper Quarter of Earnings AbbVie Lifts Profit Outlook as Sales Rise Bristol Myers Squibb Profit Soars, Raises Revenue Guidance Merck Profit Rises on Strong Keytruda Demand GSK Lifts Guidance After Specialty Medicines Boost Sales Novartis Expects to Ride Out Patent Losses With Sales, Profit Growth Ahead Biogen Cuts Full-Year Earnings Guidance, Despite Third-Quarter Profit Rise J&J Lifts Full-Year Sales Outlook, Fueled by Pharma, Med-Device Gains Learn more about your ad choices. Visit megaphone.fm/adchoices

Mark Murphy shares insights from his research on maximizing team effectiveness.— YOU'LL LEARN — 1) Why you don't want a team of all “team players”2) The simple trick for more decisive teams 3) How to get your team to generate 3X more valuable ideas Subscribe or visit AwesomeAtYourJob.com/ep1105 for clickable versions of the links below. — ABOUT MARK — Mark Murphy is a New York Times bestselling author, Senior Contributor to Forbes, andFounder of Leadership IQ, a research and training firm. His latest book is TEAM PLAYERS: The Five Critical Roles You Need to Build A Winning Team. Mark's previous bestselling books include: Hiring for Attitude, Hundred Percenters, HARD Goals, Managing Narcissists, Blamers, Dramatics and more. Mark leads one of the world's largest databases of original leadership research, and his work has appeared in The Wall Street Journal, The New York Times, Fortune, Forbes, Bloomberg, BusinessWeek, Harvard Business Review, and U.S. News & World Report. He's been a featured guest on programs including CBS News Sunday Morning, ABC's 20/20, Fox Business News, CNN International and NPR.Some of his most well-known research studies include “Why New Hires Fail,” “Are SMART Goals Dumb?,” “Why CEO's Get Fired,” “High Performers Can Be Less Engaged,” and “Don't Expect Layoff Survivors to Be Grateful.” Mark has conducted training for The United Nations, Harvard Business School, Microsoft, IBM, MasterCard, Merck, and thousands more.• Book: Team Players: The Five Critical Roles You Need to Build a Winning Team• Quiz: “Team Player Quiz: What Type Of Team Player Are You?"• Website: LeadershipIQ.com— RESOURCES MENTIONED IN THE SHOW — • Study: “Studies in the Principles of Judgments and Attitudes: II. Determination of Judgments by Group and by Ego Standards” by S.E. Asch• Book: Escape from Freedom by Erich Fromm• Past episode: 256: Science-based Solutions for Delivering Tough Truth at Work with Mark Murphy— THANK YOU SPONSORS! — • Strawberry.me. Claim your $50 credit and build momentum in your career with Strawberry.me/Awesome• Vanguard. Give your clients consistent results year in and year out with vanguard.com/AUDIO• Quince. Get free shipping and 365-day returns on your order with Quince.com/Awesome• Cashflow Podcasting. Explore launching (or outsourcing) your podcast with a free 10-minute call with Pete.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.